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Completed

NCT Number: NCT00730015

Trial of Linaclotide in Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.

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Key information

Conditions

Chronic Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ironwood Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
  • Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient demonstrates continued chronic constipation through Pretreatment Period
  • Patient is compliant with IVRS

Exclusion criteria

  • Patient has 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 could confound the study assessments

Treatment and study plan

Matching Placebo

Drug

Oral, once daily

Linaclotide

Drug

Oral, once daily

Primary outcomes

  1. Complete Spontaneous Bowel Movement (CSBM) Overall Responder

    Time frame: Change from Baseline to Week 12

    A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.

    An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

Secondary outcomes

  1. 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency

    Time frame: Change from Baseline to Week 12

    The number of CSBMs per week.

  2. 12-Week Spontaneous Bowl Movement (SBM) Frequency

    Time frame: Change from Baseline to Week 12

    The number of SBMs per week.

  3. 12-week Change in Stool Consistency

    Time frame: Change from Baseline to Week 12

    The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:

    • = 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]

  4. 12-week Change in Severity of Straining

    Time frame: Change from Baseline to Week 12

    Severity of Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount".

  5. 12-week Change in Abdominal Discomfort

    Time frame: Change from Baseline to Week 12

    Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."

  6. 12-week Change in Bloating

    Time frame: Change from Baseline to Week 12

    Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".

  7. 12-week Change in Constipation Severity

    Time frame: Change from Baseline to Week 12

    Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Jan 30, 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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