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Irritable Bowel Syndrome Characterized by ConstipationPhase 3NCT03573908

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

A Phase 3 study testing Linaclotide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Ironwood Pharmaceuticals, Inc. at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linaclotide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
614 participants
Where
79 sitesUnited States
Study dates
20 Jun 2018to 10 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Hormonal contraception
  • Double-barrier birth control
  • 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

Who cannot join

  • 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

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Alan A. Rosen, MD, PA

    Baltimore, Maryland, 21215

  • MW Clinical Research Center

    Beaumont, Texas, 77701

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02131

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59718

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010

  • Healthwise Medical Associates

    Brooklyn, New York, 11206

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28210

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc.

    Chula Vista, California, 91910

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Remington Davis, Inc.

    Columbus, Ohio, 43215

  • Carolina Digestive Health Associates

    Concord, North Carolina, 28025

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Partners In Clinical Research

    Cumberland, Rhode Island, 02864

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • Dayton Gastroenterology, Inc.

    Dayton, Ohio, 45415

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Diagnamics, Inc.

    Encinitas, California, 92024

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates PA

    Flowood, Mississippi, 39232

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Paragon Rx Clinical, Inc. - Garden Grove

    Garden Grove, California, 92840

  • Long Island Gastrointestinal Research Group, LLP

    Great Neck, New York, 11023

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • Meritus Center For Clinical Research

    Hagerstown, Maryland, 21742

  • Palmetto Research, LLC

    Hialeah, Florida, 33016

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Southwest Clinical Trials

    Houston, Texas, 77081

  • Clinical Research Associates

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • The Chappel Group Research

    Kissimmee, Florida, 34741

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Grossmont Center For Clinical Research

    La Mesa, California, 91942

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Jesscan Medical Research

    Miami, Florida, 33134

  • Well Pharma Medical Research Corporation

    Miami, Florida, 33143

  • New Horizon Research Center

    Miami, Florida, 33175

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida, 33166

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Advanced Research Institute

    Ogden, Utah, 84405

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Quality Research, Inc.

    San Antonio, Texas, 78209

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Precision Research Institute

    San Diego, California, 92114

  • Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • Paragon Rx Clinical, Inc.- Santa Ana

    Santa Ana, California, 92703

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • St. Louis Center For Clinical Research

    St Louis, Missouri, 63128

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Meridien Research - Tampa

    Tampa, Florida, 33634

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Trials of America - North Carolina, LLC

    Winston-Salem, North Carolina, 27103

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Research Institute of Central Florida, LLC

    Winter Park, Florida, 32792

  • Gastroenterology Associates of West Michigan

    Wyoming, Michigan, 49519

  • St. Joseph Heritage Healthcare

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

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.

Read the detailed description

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

Being tested
Linaclotide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinaclotideDrug

    Also called Linzess

    Oral capsule

  • PlaceboDrug

    Matching placebo oral capsule

Study groups in NCT03573908
Study groupRoleWhat they receive
Linaclotide 290 µgExperimentalParticipants 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.
Receives: Drug: Linaclotide; Drug: Placebo
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Linaclotide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

Secondary outcomes (3)

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

    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).

    Measured: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

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

    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.

    Measured: Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12)

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

    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.

    Measured: Baseline (14 days before randomization up to the time of randomization), Weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start20 Jun 2018
  3. Primary completion13 Mar 2019
  4. Study completion10 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573908
Sponsor's protocol ID
MCP-103-312
Status last verified
Nov 2020
First submitted
18 Jun 2018
Last updated
1 Dec 2020
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brenner DM, Lacy BE, Ford AC, Bartolini W, Wu J, Shea EP, Bochenek W, Boinpally R, Almansa C. Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials. Am J Gastroenterol. 2023 May 1;118(5):872-879. doi: 10.14309/ajg.0000000000002064. Epub 2022 Oct 12.

    PubMed 36227782

  • Chang L, Lacy BE, Moshiree B, Kassebaum A, Abel JL, Hanlon J, Bartolini W, Boinpally R, Bochenek W, Fox SM, Mallick M, Tripp K, Omniewski N, Shea E, Borgstein N. Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System. Am J Gastroenterol. 2021 Sep 1;116(9):1929-1937. doi: 10.14309/ajg.0000000000001334.

    PubMed 34465695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Ironwood Pharmaceuticals, Inc. at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573908, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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