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Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Primary Purpose

Irritable Bowel Syndrome With Constipation

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Linaclotide Acetate

Matching placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation focused on measuring Irritable Bowel Syndrome with Constipation, IBS, Irritable Bowel Syndrome, linaclotide acetate, linaclotide, MD-1100

Eligibility Criteria

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

Inclusion Criteria:

Must not be pregnant or breastfeeding and agree to use birth control;
Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
Demonstrates English fluency and has access to a touch-tone telephone.

Exclusion Criteria:

Recent history of mushy or watery stools;
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
Clinically-significant alarm symptoms;
Secondary causes of constipation or evacuation disorders;
Surgery to the gastrointestinal tract;
Usage of prohibited medications.

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 Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period

The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.

Secondary Outcome Measures

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

For each week of the Treatment and Posttreatment 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 the baseline weekly CSBM rate.

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

SBMs were measured daily during the treatment period by patient calls to the IVRS.

Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period

Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (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 = watery, no solid pieces (entirely liquid).

Change From Baseline in Straining (5-point Ordinal Scale) 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.

Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period

Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).

Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period

During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe

Full Information

NCT ID

NCT00460811

First Posted

April 13, 2007

Last Updated

January 29, 2013

Sponsor

Ironwood Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00460811

Brief Title

Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ironwood Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

6. Conditions and Keywords

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

Irritable Bowel Syndrome With Constipation

Keywords

Irritable Bowel Syndrome with Constipation, IBS, Irritable Bowel Syndrome, linaclotide acetate, linaclotide, MD-1100

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

420 (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 Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period

Description

Time Frame