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Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Primary Purpose

Chronic Constipation, Constipation

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Linaclotide 290 micrograms

Linaclotide 145 micrograms

Matching placebo

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Chronic Constipation, Abdominal Bloating, Linaclotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings
Patient has successfully completed protocol procedures (with no clinically significant findings)
Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:
1. Straining during more than 25% of BMs
2. Lumpy or hard stools during more than 25% of BMs
3. Sensation of incomplete evacuation during more than 25% of BMs
Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
Patient is compliant with Interactive voice response System (IVRS)

Exclusion Criteria:

Patient has a history of loose or watery stools
Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Linaclotide 290 micrograms

Linaclotide 145 Micrograms

Placebo

Arm Description

Linaclotide 290 micrograms

Linaclotide 145 micrograms

Matching placebo

Outcomes

Primary Outcome Measures

9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.

Secondary Outcome Measures

9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

Change From Baseline in 12-Week Abdominal Bloating

Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.

Percent Change From Baseline in 12-week Abdominal Bloating

Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.

Percent Change From Baseline in Abdominal Bloating at Week 12

Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.

6/12 Week Abdominal Bloating 30% Responder

A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.

Change From Baseline in 12-week CSBM Frequency Rate

A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in CSBM Frequency Rate at Week 1.

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in CSBM Frequency Rate at Week 4.

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in CSBM Frequency Rate at Week 8

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in CSBM Frequency Rate at Week 12

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in 12-Week SBM Frequency Rate

A patient's Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in SBM Frequency Rate at Week 1

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in SBM Frequency Rate at Week 4

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in SBM Frequency Rate at Week 8

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in SBM Frequency Rate at Week 12

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)

A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

SBM Within 24 Hours After the First Dose of Investigational Product

The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product

Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time). Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in 12-week Stool Consistency

Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS): = separate hard lumps like nuts [difficult to pass] = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges [passed easily] = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces [entirely liquid] A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in Stool Consistency at Week 12

Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS): = separate hard lumps like nuts [difficult to pass] = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges [passed easily] = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces [entirely liquid] A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in 12-week Severity of Straining

Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Change From Baseline in Severity of Straining at Week 12

Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

9/12 Week Mild Straining and Diarrhea-free Responder

A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Full Information

NCT ID

NCT01642914

First Posted

July 13, 2012

Last Updated

March 24, 2016

Sponsor

Forest Laboratories

Collaborators

Ironwood Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01642914

Brief Title

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Official Title

Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forest Laboratories

Collaborators

Ironwood Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation, Constipation

Keywords

Chronic Constipation, Abdominal Bloating, Linaclotide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

487 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Linaclotide 290 micrograms

Arm Type

Experimental

Arm Description

Linaclotide 290 micrograms

Arm Title

Linaclotide 145 Micrograms

Arm Type

Experimental

Arm Description

Linaclotide 145 micrograms

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

Linaclotide 290 micrograms

Intervention Description

oral capsule, taken once daily each morning at least 30 minutes before breakfast

Intervention Type

Drug

Intervention Name(s)

Linaclotide 145 micrograms

Intervention Description

oral capsule, taken once daily each morning at least 30 minutes before breakfast

Intervention Type

Drug

Intervention Name(s)

Matching placebo

Intervention Description

oral capsule, taken once daily each morning at least 30 minutes before breakfast

Primary Outcome Measure Information:

Title

9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

Description

Time Frame

12-week treatment period

Secondary Outcome Measure Information:

Title

9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

Description

Time Frame

12-week treatment period

Title

Change From Baseline in 12-Week Abdominal Bloating

Description

Time Frame

Baseline and 12-week treatment period

Title

Percent Change From Baseline in 12-week Abdominal Bloating

Description

Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.

Time Frame

Baseline and 12-week treatment period

Title

Percent Change From Baseline in Abdominal Bloating at Week 12

Description

Time Frame

Baseline and Week 12

Title

6/12 Week Abdominal Bloating 30% Responder

Description

Time Frame

12-week treatment period

Title

Change From Baseline in 12-week CSBM Frequency Rate

Description

Time Frame

Baseline and 12-week treatment period

Title

Change From Baseline in CSBM Frequency Rate at Week 1.

Description

Time Frame

Baseline and Week 1

Title

Change From Baseline in CSBM Frequency Rate at Week 4.

Description

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 4

Title

Change From Baseline in CSBM Frequency Rate at Week 8

Description

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 8

Title

Change From Baseline in CSBM Frequency Rate at Week 12

Description

A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 12

Title

Change From Baseline in 12-Week SBM Frequency Rate

Description

Time Frame

12-week treatment period

Title

Change From Baseline in SBM Frequency Rate at Week 1

Description

Time Frame

Baseline and Week 1

Title

Change From Baseline in SBM Frequency Rate at Week 4

Description

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 4

Title

Change From Baseline in SBM Frequency Rate at Week 8

Description

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 8

Title

Change From Baseline in SBM Frequency Rate at Week 12

Description

A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 12

Title

Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)

Description

Time Frame

Baseline and 12-week treatment period

Title

SBM Within 24 Hours After the First Dose of Investigational Product

Description

Time Frame

24 hours from first dose of investigational product (Day 1)

Title

Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product

Description

Time Frame

12-week treatment period

Title

Change From Baseline in 12-week Stool Consistency

Description

Time Frame

Baseline and 12-week treatment period

Title

Change From Baseline in Stool Consistency at Week 12

Description

Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS): = separate hard lumps like nuts [difficult to pass] = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges [passed easily] = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces [entirely liquid] A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 12

Title

Change From Baseline in 12-week Severity of Straining

Description

Time Frame

Baseline and 12-week treatment period

Title

Change From Baseline in Severity of Straining at Week 12

Description

Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

Time Frame

Baseline and Week 12

Title

9/12 Week Mild Straining and Diarrhea-free Responder

Description

Time Frame

12-week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings Patient has successfully completed protocol procedures (with no clinically significant findings) Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks: Straining during more than 25% of BMs Lumpy or hard stools during more than 25% of BMs Sensation of incomplete evacuation during more than 25% of BMs Patient demonstrates continued chronic constipation and bloating through Pretreatment Period Patient is compliant with Interactive voice response System (IVRS) Exclusion Criteria: Patient has a history of loose or watery stools Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Shiff, MD

Organizational Affiliation

Forest Laboratories

Official's Role

Study Director

Facility Information:

Facility Name

Forest Investigative Site 020

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Forest Investigative Site 102

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Forest Investigative Site 149

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Forest Investigative Site 126

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Forest Investigative Site 018

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Forest Investigative Site 061

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Forest Investigative Site 022

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Forest Investigative Site 079

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Forest Investigative Site 071

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Forest Investigative Site 135

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72117

Country

United States

Facility Name

Forest Investigative Site 106

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Forest Investigative Site 104

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Forest Investigative Site 066

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Forest Investigative Site 095

City

San Carlos

State/Province

California

ZIP/Postal Code

94070

Country

United States

Facility Name

Forest Investigative Site 009

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Forest Investigative Site 151

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Forest Investigative Site 010

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Forest Investigative Site 012

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Forest Investigative Site 041

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80904

Country

United States

Facility Name

Forest Investigative Site 045

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Forest Investigative Site 060

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

Forest Investigative Site 007

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Forest Investigative Site 153

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Forest Investigative Site 091

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33426

Country

United States

Facility Name

Forest Investigative Site 047

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Forest Investigative Site 042

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Forest Investigative Site 133

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Forest Investigative Site 131

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Forest Investigative Site 051

City

Ft. Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Forest Investigative Site 137

City

Inverness

State/Province

Florida

ZIP/Postal Code

34452

Country

United States

Facility Name

Forest Investigative Site 114

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Forest Investigative Site 004

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Forest Investigative Site 016

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Forest Investigative Site 097

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Forest Investigative Site 003

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Forest Investigative Site 002

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Forest Investigative Site 130

City

New Smyrna Beach

State/Province

Florida

ZIP/Postal Code

32168

Country

United States

Facility Name

Forest Investigative Site 040

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Forest Investigative Site 083

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Forest Investigative Site 150

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Forest Investigative Site 132

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Forest Investigative Site 127

City

Seminole

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

Forest Investigative Site 087

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Forest Investigative Site 064

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Forest Investigative Site 115

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Forest Investigative Site 021

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Forest Investigative Site 011

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30067

Country

United States

Facility Name

Forest Investigative Site 109

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Forest Investigative Site 037

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Forest Investigative Site 023

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

Forest Investigative Site 015

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Forest Investigative Site 122

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Forest Investigative Site 043

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Forest Investigative Site 107

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Forest Investigative Site 117

City

Clive

State/Province

Iowa

ZIP/Postal Code

50325

Country

United States

Facility Name

Forest Investigative Site 146

City

Clive

State/Province

Iowa

ZIP/Postal Code

50325

Country

United States

Facility Name

Forest Investigative Site 143

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52807

Country

United States

Facility Name

Forest Investigative Site 055

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Forest Investigative Site 028

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Forest Investigative Site 112

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Forest Investigative Site 034

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Forest Investigative Site 032

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Forest Investigative Site 128

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Forest Investigative Site 134

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Forest Investigative Site 121

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Forest Investigative Site 124

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Forest Investigative Site 101

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Forest Investigative Site 058

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Forest Investigative Site 099

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Forest Investigative Site 062

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Forest Investigative Site 008

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Forest Investigative Site 014

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

Forest Investigative Site 024

City

Towson

State/Province

Maryland

ZIP/Postal Code

21286

Country

United States

Facility Name

Forest Investigative Site 006

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Forest Investigative Site 070

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Forest Investigative Site 145

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Forest Investigative Site 141

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Forest Investigative Site 077

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Forest Investigative Site 048

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Forest Investigative Site 052

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Forest Investigative Site 080

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89121

Country

United States

Facility Name

Forest Investigative Site 036

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

Forest Investigative Site 088

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Forest Investigative Site 033

City

Vineland

State/Province

New Jersey

ZIP/Postal Code

08360

Country

United States

Facility Name

Forest Investigative Site 063

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Forest Investigative Site 093

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

Forest Investigative Site 044

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11206

Country

United States

Facility Name

Forest Investigative Site 017

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Forest Investigative Site 142

City

Asheboro

State/Province

North Carolina

ZIP/Postal Code

27203

Country

United States

Facility Name

Forest Investigative Site 094

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Forest Investigative Site 075

City

Boone

State/Province

North Carolina

ZIP/Postal Code

28607

Country

United States

Facility Name

Forest Investigative Site 123

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7080

Country

United States

Facility Name

Forest Investigative Site 140

City

Davidson

State/Province

North Carolina

ZIP/Postal Code

28036

Country

United States

Facility Name

Forest Investigative Site 039

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Forest Investigative Site 031

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Forest Investigative Site 029

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Forest Investigative Site 078

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Forest Investigative Site 084

City

Harrisburg

State/Province

North Carolina

ZIP/Postal Code

28075

Country

United States

Facility Name

Forest Investigative Site 073

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Forest Investigative Site 050

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Forest Investigative Site 139

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Forest Investigative Site 027

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Forest Investigative Site 119

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Forest Investigative Site 089

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Forest Investigative Site 074

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Forest Investigative Site 025

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Forest Investigative Site 120

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Forest Investigative Site 056

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Forest Investigative Site 026

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Forest Investigative Site 098

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45415

Country

United States

Facility Name

Forest Investigative Site 090

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Forest Investigative Site 085

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Forest Investigative Site 068

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

Forest Investigative Site 118

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Forest Investigative Site 081

City

Levittown

State/Province

Pennsylvania

ZIP/Postal Code

19056

Country

United States

Facility Name

Forest Investigative Site 001

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Forest Investigative Site 110

City

Reading

State/Province

Pennsylvania

ZIP/Postal Code

19606

Country

United States

Facility Name

Forest Investigative Site 116

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Forest Investigative Site 046

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

Forest Investigative Site 092

City

Dakota Dunes

State/Province

South Dakota

ZIP/Postal Code

57049

Country

United States

Facility Name

Forest Investigative Site 129

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Forest Investigative Site 138

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Forest Investigative Site 125

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Forest Investigative Site 035

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Forest Investigative Site 005

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Forest Investigative Site 111

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

Facility Name

Forest Investigative Site 100

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Forest Investigative Site 067

City

Katy

State/Province

Texas

ZIP/Postal Code

77450

Country

United States

Facility Name

Forest Investigative Site 049

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77505

Country

United States

Facility Name

Forest Investigative Site 030

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Forest Investigative Site 076

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Forest Investigative Site 065

City

Sugarland

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Forest Investigative Site 019

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Forest Investigative Site 105

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Forest Investigative Site 113

City

Sandy

State/Province

Utah

ZIP/Postal Code

84094

Country

United States

Facility Name

Forest Investigative Site 053

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Forest Investigative Site 108

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Forest Investigative Site 136

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Forest Investigative Site 148

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

Forest Investigative Site 072

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

Facility Name

Forest Investigative Site 069

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Forest Investigative Site 013

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Forest Investigative Site 038

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Forest Investigative Site 103

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Forest Investigative Site 082

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

Forest Investigative Site 096

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Forest Investigative Site 059

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Forest Investigative Site 054

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

Facility Name

Forest Investigative Site 086

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Forest Investigative Site 147

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Forest Investigative Site 152

City

Vaughan

State/Province

Ontario

ZIP/Postal Code

L4L 4Y7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

33428631

Citation

Lacy BE, Shea EP, Manuel M, Abel JL, Jiang H, Taylor DCA. Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications. PLoS One. 2021 Jan 11;16(1):e0243318. doi: 10.1371/journal.pone.0243318. eCollection 2021.

Results Reference

derived

PubMed Identifier

26222318

Citation

Lacy BE, Schey R, Shiff SJ, Lavins BJ, Fox SM, Jia XD, Blakesley RE, Hao X, Cronin JA, Currie MG, Kurtz CB, Johnston JM, Lembo AJ. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial. PLoS One. 2015 Jul 29;10(7):e0134349. doi: 10.1371/journal.pone.0134349. eCollection 2015.

Results Reference

derived

Learn more about this trial

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

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Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Chronic Constipation, Constipation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial