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Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

linaclotide acetate

Matching placebo

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation, Chronic Constipation, Microbia, linaclotide, linaclotide acetate, MD-1100

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is 18 years of age or older
Patient meets colonoscopy requirements according to the American Gastroenterological Association
Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
Patient is fluent in English

Exclusion Criteria:

Patient reports loose or watery stools
Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
Patient may not take prohibited medications per protocol
Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

72 ug linaclotide acetate

145 ug linaclotide acetate

290 ug linaclotide acetate

579 ug linaclotide acetate

Matching Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Secondary Outcome Measures

SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate.

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate.

Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period

CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?

Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period

Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.

Change From Baseline in Straining Score for the Treatment Period

Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.

Full Information

NCT ID

NCT00402337

First Posted

November 18, 2006

Last Updated

January 29, 2013

Sponsor

Ironwood Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00402337

Brief Title

Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Official Title

A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ironwood Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

6. Conditions and Keywords

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

Chronic Constipation

Keywords

Constipation, Chronic Constipation, Microbia, linaclotide, linaclotide acetate, MD-1100

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

72 ug linaclotide acetate

Arm Type

Active Comparator

Arm Title

145 ug linaclotide acetate

Arm Type

Active Comparator

Arm Title

290 ug linaclotide acetate

Arm Type

Active Comparator

Arm Title

579 ug linaclotide acetate

Arm Type

Active Comparator

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

linaclotide acetate

Intervention Description

oral, once daily.

Intervention Type

Drug

Intervention Name(s)

Matching placebo

Intervention Description

oral, once daily

Primary Outcome Measure Information:

Title

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

Description

Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Time Frame