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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

NCTNCT00765882 (opens ClinicalTrials.gov in a new tab)Other idLIN-MD-01
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Canada

Start
Sept 2008
Primary completion
Jul 2009
Completion
Aug 2009
First posted
3 Oct 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

    Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

    NCT00765882

    Sept 2008 to Aug 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 treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Interventions

  • Linaclotide 290 microgramsDrug
  • Linaclotide 145 microgramsDrug
  • PlaceboDrug

Arms3

  • Experimental

    1

    Linaclotide 290 micrograms

  • Experimental

    2

    Linaclotide 145 micrograms

  • Placebo comparator

    3

    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 responders 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 Rate

    Time frame · Change from Baseline to Week 12

    Registry description

    The number of CSBMs per week.

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

    Time frame · Change from Baseline to Week 12

    Registry description

    A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.

  3. 12-Week 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 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 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 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 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)
Placebo13
Linaclotide 145µg34
Linaclotide 290µg43
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

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

GroupValue (CSBM per week)Spread
Placebo0.6140.209
Linaclotide 145µg2.0110.215
Linaclotide 290µg2.6530.217
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Spontaneous Bowel Movement (SBM) Frequency Rate

GroupValue (SBM per week)Spread
Placebo1.1130.265
Linaclotide 145µg3.4660.272
Linaclotide 290µg3.6750.275
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Stool Consistency

GroupValue (units on a scale)Spread
Placebo0.5720.098
Linaclotide 145µg1.8230.100
Linaclotide 290µg2.0090.103
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Severity of Straining

GroupValue (units on a scale)Spread
Placebo-0.5540.060
Linaclotide 145µg-1.1410.061
Linaclotide 290µg-1.2080.063
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Abdominal Discomfort

GroupValue (units on a scale)Spread
Placebo-0.2710.043
Linaclotide 145µg-0.4550.044
Linaclotide 290µg-0.4850.045
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Bloating

GroupValue (units on a scale)Spread
Placebo-0.2440.048
Linaclotide 145µg-0.4320.049
Linaclotide 290µg-0.4850.049
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

12-Week Constipation Severity

GroupValue (units on a scale)Spread
Placebo-0.3060.062
Linaclotide 145µg-0.9080.063
Linaclotide 290µg-0.9540.064

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.–4 / 21535 / 215
Linaclotide 145µgLinaclotide, 145µg dose, oral administration, once per day–3 / 21370 / 213
Linaclotide 290µgLinaclotide, 290µg dose, oral administration, once per day–7 / 20549 / 205

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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