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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Trial of Linaclotide in Patients With Chronic Constipation

NCTNCT00730015 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-303
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Aug 2008
Primary completion
Aug 2009
Completion
Oct 2009
First posted
8 Aug 2008 (estimated)
Last update posted
30 Jan 2013 (estimated)
Conditions
Chronic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 3

    Trial of Linaclotide in Patients With Chronic Constipation

    NCT00730015

    Aug 2008 to Oct 2009

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 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.

Interventions

  • Matching PlaceboDrug
  • LinaclotideDrug

Arms3

  • Experimental

    145 μg linaclotide

  • Experimental

    290 μg linaclotide

  • Placebo comparator

    Matching Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Complete Spontaneous Bowel Movement (CSBM) Overall Responder

    Time frame · Change from Baseline to Week 12

    Registry description

    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(7)

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

    Time frame · Change from Baseline to Week 12

    Registry description

    The number of CSBMs per week.

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

    Time frame · Change from Baseline to Week 12

    Registry description

    The number of SBMs per week.

  3. 12-week Change in Stool Consistency

    Time frame · Change from Baseline to Week 12

    Registry description

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

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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".

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

Complete Spontaneous Bowel Movement (CSBM) Overall Responder

GroupValue (participants)
Linaclotide, 145μg46
Linaclotide, 290μg42
Placebo7
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency

GroupValue (CSBMs per Week)Spread
Linaclotide, 145μg1.940.17
Linaclotide, 290μg2.040.17
Placebo0.450.17
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Spontaneous Bowl Movement (SBM) Frequency

GroupValue (SBMs per Week)Spread
Linaclotide, 145μg3.030.21
Linaclotide, 290μg2.980.21
Placebo1.080.22
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-week Change in Stool Consistency

GroupValue (units on a scale)Spread
Linaclotide, 145μg1.850.08
Linaclotide, 290μg1.840.08
Placebo0.580.09
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-week Change in Severity of Straining

GroupValue (units on a scale)Spread
Linaclotide, 145μg-1.120.05
Linaclotide, 290μg-1.150.05
Placebo-0.510.05
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-week Change in Abdominal Discomfort

GroupValue (units on a scale)Spread
Linaclotide, 145μg-0.490.04
Linaclotide, 290μg-0.440.04
Placebo-0.300.04
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-week Change in Bloating

GroupValue (units on a scale)Spread
Linaclotide, 145μg-0.460.04
Linaclotide, 290μg-0.370.04
Placebo-0.220.04
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-week Change in Constipation Severity

GroupValue (units on a scale)Spread
Linaclotide, 145μg-0.900.05
Linaclotide, 290μg-0.810.05
Placebo-0.270.05

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Linaclotide 145μgLinaclotide, 145μg dose, oral administration, once per day–3 / 21727 / 217
Linaclotide 290μgLinaclotide, 290μg dose, oral administration, once per day–4 / 21730 / 217
PlaceboDose matched placebo, oral administration, once per day–5 / 20914 / 209
Placebo to Linaclotide 290μg Randomized Withdrawal (RW) PeriodDose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.–0 / 17720 / 177
Linaclotide 145μg to Placebo RW PeriodLinaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day–2 / 951 / 95
Linaclotide 145μg to Linaclotide 145μg RW PeriodLinaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day–0 / 902 / 90
Linaclotide 290μg to Placebo RW PeriodLinaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day–0 / 860 / 86
Linaclotide 290μg to Linaclotide 290μg RW PeriodLinaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day–0 / 901 / 90

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

2 results

The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials.

Chang et al. 2014Alimentary pharmacology & therapeuticscited by 26

PMID 25312449PMC4278547DOI 10.1111/apt.12985PUB-25312449

Free to read · publisher termsCC BY-NC-ND2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2011

9 results

Two randomized trials of linaclotide for chronic constipation.

Lembo et al. 2011The New England journal of medicinecited by 272

PMID 21830967DOI 10.1056/nejmoa1010863PUB-21830967

Full text at the publisher9 results
Publisher pageSee results (9)

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 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

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