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Completed

NCT Number: NCT00948818

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

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Key information

Conditions

Irritable Bowel Syndrome Characterized by Constipation Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 113, Greater Sudbury, Ontario, 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

  • Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
  • Relieved with defecation
  • Onset associated with a change in frequency of stool
  • Onset associated with a change in form (appearance) of stool
  • Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
  • Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion criteria

  • Patient has history of loose or watery stools for >25% of BMs
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments

Treatment and study plan

Linaclotide 290 micrograms

Drug

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Matching Placebo

Drug

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Primary outcomes

  1. Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks

    Time frame: Change from Baseline to Week 12

    A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.

    The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.

    A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.

  2. Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks

    Time frame: Change from Baseline to Week 12

    A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.

    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.

  3. Abdominal Pain Responder, 9 Out of 12 Weeks

    Time frame: Change from Baseline to Week 12

    A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.

    The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

  4. Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.

    Time frame: Change from Baseline to Week 12

    A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.

    The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.

    A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.

Secondary outcomes

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

    Time frame: Change from Baseline to Week 12

    The number of CSBMs per week.

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

    Time frame: Change from Baseline to Week 12

    The number of Spontaneous Bowl Movements experienced per week.

  3. 12-Week Stool Consistency

    Time frame: Change from Baseline to Week 12

    The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.

    • = 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 Severity of Straining

    Time frame: Change from Baseline to Week 12

    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 Pain Score

    Time frame: Change from Baseline to Week 12

    Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

  6. 12-Week Change in Abdominal Discomfort

    Time frame: Change from Baseline to Week 12

    Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."

  7. 12-Week Change in Bloating

    Time frame: Change from Baseline to Week 12

    Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".

  8. Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment

    Time frame: Change from Baseline to Week 12

    A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.

  9. Abdominal Pain Responder for 6 Out of 12 Weeks

    Time frame: Change from Baseline to Week 12

    A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.

    The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

  10. 12-Week Percent of Abdominal Pain-free (APF) Days

    Time frame: Change from Baseline to Week 12

    Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst

    Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Ironwood Pharmaceuticals, Inc.

Registry information

Official study title

A Phase III, 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 Irritable Bowel Syndrome With Constipation

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2009
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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