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Completed

NCT Number: NCT00460811

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

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.

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Key information

Conditions

Irritable Bowel Syndrome With Constipation Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Microbia Investigational Site, Abbortsford, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

linaclotide acetate

Drug

Oral, once daily

Matching Placebo

Drug

Oral, once daily

Primary outcomes

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

    Time frame: Change from Baseline to Week 12

    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 outcomes

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

    Time frame: Change from Baseline to Week 12

    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.

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

    Time frame: Change from Baseline to Week 12

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

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

    Time frame: Change from Baseline to Week 12

    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).

  4. Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period

    Time frame: Change from Baseline to Week 12

    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.

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

    Time frame: Change from Baseline to Week 12

    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).

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

    Time frame: Change from Baseline to Week 12

    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

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2007
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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