Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00948818 (opens ClinicalTrials.gov in a new tab)Other idLIN-MD-31
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
803 participants (actual)
Sponsor
Forest Laboratories · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

United States, Canada

Start
Jul 2009
Primary completion
Jul 2010
Completion
Aug 2010
First posted
29 Jul 2009 (estimated)
Last update posted
30 Jan 2013 (estimated)
Conditions
Irritable Bowel Syndrome Characterized by 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 Administered to Patients With Irritable Bowel Syndrome With Constipation

    NCT00948818

    Jul 2009 to Aug 2010

Registry summary

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

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.

Interventions

  • Linaclotide 290 microgramsDrug
  • Matching placeboDrug

Arms2

  • Experimental

    Linaclotide

    Linaclotide 290 micrograms

  • Placebo comparator

    Placebo

    Matching placebo

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 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

    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 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

    Registry description

    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(10)

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

    Time frame · Change from Baseline to Week 12

    Registry description

    The number of CSBMs per week.

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

    Time frame · Change from Baseline to Week 12

    Registry description

    The number of Spontaneous Bowl Movements experienced per week.

  3. 12-Week 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 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 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

    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 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

    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)
Placebo20
Linaclotide49
Primary outcomeNumber· Change from Baseline to Week 12

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

GroupValue (Participant)
Placebo25
Linaclotide79
Primary outcomeNumber· Change from Baseline to Week 12

Abdominal Pain Responder, 9 Out of 12 Weeks

GroupValue (Participants)
Placebo107
Linaclotide139
Primary outcomeNumber· Change from Baseline to Week 12

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

GroupValue (Participants)
Placebo83
Linaclotide136
Secondary and other outcome results(4)
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

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

GroupValue (CSBMs per Week)Spread
Placebo0.7050.128
Linaclotide2.2720.127
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Spontaneous Bowl Movement (SBM) Frequency Rate

GroupValue (SBMs per week)Spread
Placebo1.130.0177
Linaclotide3.8980.176
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Stool Consistency

GroupValue (units on a scale)Spread
Placebo0.6620.061
Linaclotide2.0710.060
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Severity of Straining

GroupValue (units on a scale)Spread
Placebo-0.6510.042
Linaclotide-1.3060.042

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo - Treatment PeriodDose-matched placebo, oral administration, once per day.–2 / 39622 / 396
Linaclotide - Treatment PeriodLinaclotide 290µg, oral administration, once per day.–2 / 40693 / 406
Placebo to Linaclotide - Randomized Withdrawal PeriodLinaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period. This group had previously received dose-matched placebo during the 12-week randomized treatment period.–0 / 33341 / 333
Linaclotide to Placebo - Randomized Withdrawal PeriodDose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period. This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period.–0 / 1541 / 154
Linaclotide to Linaclotide - Randomized Withdrawal PeriodLinaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period–0 / 1585 / 158

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 meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features: 1. Relieved with defecation 2. Onset associated with a change in frequency of stool 3. 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

PepBank is a research reference. Talk to a doctor before you use any peptide.