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Completed

NCT Number: NCT00938717

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

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Key information

Conditions

Irritable Bowel Syndrome With 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 diagnosis of IBS-C
  • Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
  • 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

Linaclotide or Matching Placebo

Drug

Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

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

    The AP score assesses patient's worst 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.

    SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM 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 patient's worst 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 to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.

    The AP score assesses patient's worst 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.

    SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.

Secondary outcomes

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

    Time frame: Change from Baseline to Week 12

    The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).

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

    Time frame: Change from Baseline to Week 12

    The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).

  3. 12-Week Change in 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 Change in 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 was assessed 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 AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.

  10. 12-Week Percent of Abdominal Pain-free 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

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 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2009
Registry last updated
Nov 5, 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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