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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCTNCT03573908 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-312
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
20 Jun 2018
Primary completion
13 Mar 2019
Completion
10 Apr 2019
First posted
29 Jun 2018
Last update posted
1 Dec 2020
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
201820192020
  1. Ph 3

    A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT03573908

    20 Jun 2018 to 10 Apr 2019

Registry summary

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

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Interventions

  • LinaclotideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Linaclotide 290 µg

    Participants receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are rerandomized to receive either linaclotide 290 µg or placebo for 4 weeks in the Randomized Withdrawal Period.

  • Placebo comparator

    Placebo

    Participants receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period

    Time frame · Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

    Registry description

    A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period and used as the dependent variable in the mixed model with repeated measures (MMRM) model. MMRM results are based on a model with treatment, analysis week, region and treatment-by-week interaction as fixed effects and baseline as a covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect.

Secondary outcomes(3)

  1. Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score

    Time frame · Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

    Registry description

    A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The 12-week abdominal score was the average of the non-missing abdominal scores reported over the course of the treatment period. Change from baseline (BL) was calculated as the 12-week score minus the baseline score. The table presents the percentage of participants whose 12-week change from baseline was less than or equal to the threshold value of the score change (cumulative distribution of change).

  2. Percentage of 6/12 Week Abdominal Score Responders (Responder Rate)

    Time frame · Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

    Registry description

    A 6/12 week abdominal score responder is a participant who meets the weekly abdominal score responder criteria for at least 6 out of the 12 weeks of the Treatment Period. For each week in the Treatment Period, a weekly abdominal score responder is a participant who has an improvement from baseline of at least 2 points (ie, a -2 point change from baseline) in the respective weekly abdominal score. If a participant did not have at least 4 completed eDiary entries for a particular Treatment Period week, the participant was not considered a responder for that week. A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period.

  3. Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period

    Time frame · Baseline (14 days before randomization up to the time of randomization), Weeks 1-12

    Registry description

    A participant's daily abdominal score was calculated as the average of daily e-diary abdominal pain, abdominal bloating and abdominal discomfort scores, each based on an 11-point scale of 0 (none) and 10 (worst possible). Baseline abdominal score was derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. The participant's abdominal score was averaged on a weekly basis, and each weekly change from baseline was calculated for the treatment period and used as the dependent variable in the mixed model with repeated measures (MMRM) model. MMRM results are based on a model with treatment, analysis week, region and treatment-by-week interaction as fixed effects and baseline as a covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect.

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 outcomeLeast squares mean· Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period

GroupValue (score on a scale)Spread
Placebo-1.1820.109
Linaclotide 290 µg-1.8980.111
Secondary and other outcome results(3)
Secondary outcomeNumber· Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

Cumulative Distribution of Change From Baseline in 12-Week Abdominal Score

GroupValue (percentage of participants)
Placebo0.0
Linaclotide 290 µg0.3
Secondary outcomeNumber· Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

Percentage of 6/12 Week Abdominal Score Responders (Responder Rate)

GroupValue (percentage of participants)
Placebo23.4
Linaclotide 290 µg40.5
Secondary outcomeLeast squares mean· Baseline (14 days before randomization up to the time of randomization), Weeks 1-12

Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Over Time in the Treatment Period

GroupValue (score on a scale)Spread
Placebo-0.4900.085
Linaclotide 290 µg-0.9250.087

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants randomized to receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period.0 / 3082 / 30815 / 308
Linaclotide 290 µgParticipants randomized to receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period.0 / 3064 / 30626 / 306
Linaclotide 290 µg -> Linaclotide 290 µgParticipants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to continue linaclotide 290 µg for 4 weeks in the Randomized Withdrawal Period.0 / 1381 / 1385 / 138
Linaclotide 290 µg -> PlaceboParticipants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to receive placebo for 4 weeks in the Randomized Withdrawal Period.0 / 1370 / 1374 / 137
Placebo -> Linaclotide 290 µgParticipants who received placebo orally once daily for 12 weeks during the Treatment Period were switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.0 / 2791 / 27921 / 279

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

PubMed tag: none · 2023

5 results

Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials.

Brenner et al. 2023The American journal of gastroenterologycited by 16

PMID 36227782PMC10144280DOI 10.14309/ajg.0000000000002064PUB-36227782

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2021

4 results

Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.

Chang et al. 2021The American journal of gastroenterologycited by 36

PMID 34465695DOI 10.14309/ajg.0000000000001334PUB-34465695

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

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 no clinically significant findings on a physical examination and clinical laboratory tests * Female patients of childbearing potential must agree to use one of the following methods of birth control: 1. Hormonal contraception 2. Double-barrier birth control 3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy * Patient meets protocol criteria for diagnosis of IBS-C * Patient demonstrates continued IBS-C symptoms through Pretreatment Period * Patient maintains a minimum level of compliance with daily diary 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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