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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00938717 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-302
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
805 participants (actual)
Sponsor
Ironwood Pharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jul 2009
Primary completion
Sept 2010
Completion
Sept 2010
First posted
14 Jul 2009 (estimated)
Last update posted
5 Nov 2013 (estimated)
Conditions
Irritable Bowel Syndrome With Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 3

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

    NCT00938717

    Jul 2009 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Linaclotide or Matching PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

  • Experimental

    290 μg Linaclotide

Primary outcomes4

Outcomes the sponsor listed as primary.

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

    Time frame · Change from Baseline to Week 12

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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(10)

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

    Time frame · Change from Baseline to Week 12

    Registry description

    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

    Registry description

    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

    Registry description

    The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7. 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 7. = watery, no solid pieces \[entirely liquid\]).

  4. 12-Week Change in Severity of Straining

    Time frame · Change from Baseline to Week 12

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Change from Baseline to Week 12

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

GroupValue (participants)
Placebo12
Linaclotide51
Primary outcomeNumber· Change from Baseline to Week 12

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

GroupValue (participants)
Placebo20
Linaclotide72
Primary outcomeNumber· Change from Baseline to Week 12

Abdominal Pain Responder, 9 Out of 12 Weeks

GroupValue (participants)
Placebo79
Linaclotide156
Primary outcomeNumber· Change from Baseline to Week 12

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

GroupValue (participants)
Placebo56
Linaclotide135
Secondary and other outcome results(4)
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency

GroupValue (CSBMs per Week)Spread
Placebo0.700.12
Linaclotide2.240.12
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Spontaneous Bowl Movement (SBM) Frequency

GroupValue (SBMs per Week)Spread
Placebo1.310.18
Linaclotide4.020.18
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Change in Stool Consistency

GroupValue (Units on a scale)Spread
Placebo0.610.06
Linaclotide1.910.06
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Change in Severity of Straining

GroupValue (Units on a scale)Spread
Placebo-0.660.05
Linaclotide-1.240.04

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboDose-matched placebo, oral administration, once per day.–7 / 40386 / 403
LinaclotideLinaclotide 290μg, oral administration, once per day.–4 / 402137 / 402

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

4 results

Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation.

Rao et al. 2014Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Associationcited by 51

PMID 24075889DOI 10.1016/j.cgh.2013.09.022PUB-24075889

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2013

8 results

Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints.

Quigley et al. 2013Alimentary pharmacology & therapeuticscited by 97

PMID 23116208DOI 10.1111/apt.12123PUB-23116208

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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