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Irritable Bowel Syndrome With ConstipationPhase 4NCT02590432

An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

A Phase 4 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation, run by Forest Laboratories 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
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Trial summary

The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with… 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?
No, everyone receives an active treatment
How many people
828 participants
Where
79 sitesUnited States
Study dates
1 Nov 2015to 5 Feb 2018
Phase
Phase 4
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

  • Participants meet the Rome III criteria for IBS-C or CIC:
  • IBS-C Criteria: the participant must meet the following 2 criteria (A and B).
  • IBS Criteria: The participant must have abdominal pain or discomfort at least 3 days per month in the 3 months before diagnosis (with symptom onset at least 6 months before diagnosis) associated with 2 or more of the following:
  • Improvement with defecation.
  • Onset associated with a change in frequency of stool.
  • Onset associated with a change in form (appearance) of stool. B. Stool Consistency Requirement: During the 3 months before diagnosis in the absence of laxative or enema use, the patient has hard or lumpy stools (Bristol Stool Form Scale [BSFS] score 1 or 2) with at least 25% of bowel movements (BMs) and has loose or mushy stools (BSFS 5 or 6) with <25% of BMs.
Show all 16Show fewer
  • CIC Criteria: the participant must meet the following 3 criteria (A, B, and C):
  • Participant meets 2 or more of the following criteria for 3 months before the diagnosis with symptom onset at least 6 months before diagnosis:
  • Straining during at least 25% of defecations.
  • Lumpy or hard stools in at least 25% of defecations.
  • Sensation of incomplete evacuation for at least 25% of defecations.
  • Sensation of anorectal obstruction/blockage for at least 25% of defecations.
  • Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor).
  • Fewer than 3 defecations per week. B. Loose stools are rarely present without the use of laxatives. C. Insufficient criteria for irritable bowel syndrome. (The criteria for IBS are provided in Point A under IBS Criteria, above).
  • Participant meets the colonoscopy requirements, which are modified from the Summary of the US-Multi-Society Task Force on Colorectal Cancer and other Colonoscopy Requirements.
  • Participant has successfully completed protocol procedures (with no clinically significant findings).

Who cannot join

  • At Day 1 visit, the participant reports having 6 or more spontaneous bowel movements (SBMs) in the week prior to screening.
  • At Day 1 visit, the participant reports having any SBMs that were watery (BSFS=7) or more than 1 SBM that was mushy (BSFS=6) in the week prior to screening.
  • Participant has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility.
  • Participant has any protocol excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments.
  • Participant has ever received linaclotide as a treatment (including commercially-available product) or has been randomized into any clinical study in which linaclotide was a treatment. (participant who enrolled into linaclotide clinical studies conducted prior or during this study but failed to be randomized are eligible for the current study).
  • Participant has ever received plecanatide, SP-333, or has participated in a plecanatide clinical study.

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • The Center for Clinical Trials, Inc.

    Biloxi, Mississippi, 39531

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • ZASA Clinical Research

    Boynton Beach, Florida, 33472

  • Meridien Research

    Bradenton, Florida, 34201

  • Clinical Research of Brandon LLC

    Brandon, Florida, 33511

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • UNC Health Care, University of North Carolina Medical Center, Memorial Hospital

    Chapel Hill, North Carolina, 27514

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Alliance Clinical Research

    Childersburg, Alabama, 35044

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Iowa Digestive Center, PC

    Clive, Iowa, 50325

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Global Clinical Trials LLC

    Costa Mesa, California, 92627

  • Partners In Clinical Research

    Cumberland, Rhode Island, 02864

  • Clinical Inquest Center LTD

    Dayton, Ohio, 45419

  • Dayton Gastroenterology, Inc.

    Dayton, Ohio, 45440

  • Lynn Institute of Denver

    Denver, Colorado, 80246

  • Diagnamics Inc

    Encinitas, California, 92024

  • Aa Mrc Llc

    Flint, Michigan, 48503

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Research Center of Fresno, Inc.

    Fresno, California, 93702

  • VVCRD Clinical Research

    Garden Grove, California, 92845

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Greenville Pharmaceutical Research, Inc.

    Greenville, South Carolina, 29615

  • Radiant Research, Inc.

    Greer, South Carolina, 29651

  • Drug Trials America

    Hartsdale, New York, 10530

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • Houston Endoscopy & Research Center

    Houston, Texas, 77079

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Northstate Clinical Research

    Lenoir, North Carolina, 38645

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Florida Medical Center and Research, Inc.

    Miami, Florida, 33142

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • KAMP Medical Research Inc

    Natchitoches, Louisiana, 71457

  • Manhattan Medical Research Practice PLLC

    New York, New York, 10016

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758-1802

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Preferred Primary Care Physicians, INC

    Pittsburgh, Pennsylvania, 15236

  • Research Across America

    Plano, Texas, 75093

  • Accord Clinical Research

    Port Orange, Florida, 32129

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Digestive Health Associates

    Reno, Nevada, 89511

  • Rockford Gastroenterology Associates

    Rockford, Illinois, 611047

  • Clinical Trials Research

    Sacramento, California, 95821

  • Northern California Research

    Sacramento, California, 95821

  • Sun Research Institute

    San Antonio, Texas, 78125

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Precision Research Institute

    San Diego, California, 92114

  • Radiant Research, Inc.

    Scottsdale, Arizona, 85251

  • Montgomery Medical, Inc.

    Smithfield, Pennsylvania, 15478

  • Coastal Research Associates, Inc.

    South Weymouth, Massachusetts, 02190

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Clinical Research Institute of Arizona, LLC

    Surprise, Arizona, 85374

  • Clinical Research Consortium

    Tempe, Arizona, 85283

  • Desert Sun Clinical Research, LLC.

    Tucson, Arizona, 85710

  • Empire Clinical Research

    Upland, California, 91786

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: An Open-label, Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation.

The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.

Read the detailed description

This study includes up to a 3-week Screening Period, followed by a 52-week treatment period. Participants with CIC meeting the entry criteria received linaclotide 145 μg capsules, orally, once daily and participants with IBS-C meeting the entry criteria received linaclotide 290 μg capsules, orally, once daily. Participants with intolerable Adverse Events (AEs), following resolution of the AEs, could be randomized to receive 290 μg, 145 μg, or the lower dose of 72 μg linaclotide oral capsules for IBS-C; and 145 μg or 72 μg for CIC. Participants who experienced further intolerable AEs after the randomization could be transitioned to open-label 72 μg linaclotide.

Being tested
Linaclotide
Keywords
Immunogenicity, Irritable Bowel Syndrome with Constipation, Chronic Idiopathic Constipation, Linaclotide, Linzess

What participants receive

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

  • LinaclotideDrug

    Also called LINZESS®

    Linaclotide capsules, orally, once daily.

Study groups in NCT02590432
Study groupRoleWhat they receive
LINZESS® 145 μg (CIC, Open Label)ExperimentalLINZESS® (linaclotide) 145 μg capsules, orally, once daily for up to 52 weeks for participants with CIC. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
Receives: Drug: Linaclotide
LINZESS® 290 μg (IBS-C, Open Label)ExperimentalLINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
Receives: Drug: Linaclotide
LINZESS® 290 μg (IBS-C, Double Blind)ExperimentalFollowing participation in the Open Label Treatment Period, LINZESS® 290 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
Receives: Drug: Linaclotide
LINZESS® 145 μg (IBS-C, Double Blind)ExperimentalFollowing participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
Receives: Drug: Linaclotide
LINZESS® 72 μg (IBS-C, Double Blind)ExperimentalFollowing participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
Receives: Drug: Linaclotide
LINZESS® 145 μg (CIC, Double Blind)ExperimentalFollowing participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was reduced to 72 μg, if applicable.
Receives: Drug: Linaclotide
LINZESS® 72 μg (CIC, Double Blind)ExperimentalFollowing participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
Receives: Drug: Linaclotide
LINZESS® 72 μg (CIC, Dose-reduced Open Label)ExperimentalFollowing participation in the Double-blind Treatment Period, if an intolerable AE occurred, LINZESS® 72 μg capsules, orally, once daily up to Week 52 for participants with CIC.
Receives: Drug: Linaclotide
LINZESS® 72 μg (IBS-C, Dose-reduced Open Label)ExperimentalFollowing participation in the Double-blind Treatment Period, if an intolerable AE occurred, LINZESS® 72 μg capsules, orally, once daily up to Week 52 for participants with IBS-C.
Receives: Drug: Linaclotide

What is being measured

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

  1. Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum

    Participants who met either of the following criteria: 1) treatment-induced ADA-positive (≥ 1 postbaseline ADA-positive sample) for baseline ADA negative or ADA-undetermined participants or 2) treatment-boosted ADA-positive (≥ 1 postbaseline ADA-positive sample with titer values ≥ 4-fold the baseline titer value) for baseline ADA-positive participants were reported as a ADA positive responder.

    Measured: Baseline (Day 1) up to 52 weeks or 8 months post last dose if ADA positive at Week 52 (approximately 84 weeks)

Secondary outcomes (10)

  1. Change From Baseline in Participant's Assessment of Constipation Severity

    Participants rated constipation severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement.

    Measured: Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)

  2. Change From Baseline in Participant Assessment of Irritable Bowel Syndrome (IBS) Symptom Severity for Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

    Participants rated IBS symptoms severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement.

    Measured: Baseline (Day 1) to Week 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)

  3. Change From Baseline in Degree of Relief of IBS Symptoms for Participants With IBS-C

    Participants rated degree of relief of IBS symptoms during previous 7 days on a 7-point balanced ordinal scale where, 1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse and 7=as bad as I can imagine. Lower scores indicate greater relief. A negative change from Baseline indicates improvement.

    Measured: Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)

  4. IBS Treatment Satisfaction Assessment Postbaseline for Participants With IBS-C

    Participants rated degree of satisfaction with the LINZESS®'s ability to relieve IBS symptoms on a 5-point ordinal scale where, 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction.

    Measured: Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)

  5. Constipation Treatment Satisfaction Assessment Postbaseline for Participants With Chronic Idiopathic Constipation (CIC)

    Participants rated degree of satisfaction with LINZESS®'s ability to relieve constipation symptoms on a 5-point ordinal scale where 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction.

    Measured: Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)

  6. Number of Participants With Recurrence of Diarrhea

    Participant reporting any instance of diarrhea during the Double-blind Treatment Period.

    Measured: From first dose in the Double-blind Treatment Period to Week 52

  7. Number of Participants With Recurrence of Intolerable Diarrhea

    Participants reporting any instance of intolerable diarrhea during the Double-blind Treatment Period (Non-responder otherwise). Only includes participants reporting intolerable diarrhea during the Open-label Treatment Period.

    Measured: From first dose in the Double-blind Treatment Period to Week 52

  8. Percentage of Participants With Treatment Emergent Adverse Events (TEAE)

    An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.

    Measured: From first dose of study treatment up to Week 52

  9. Time to First Recurrence of Diarrhea

    Time to first recurrence of diarrhea was defined as event/censored date - double-blind start date + 1, where event date (responders) = first recurrence of diarrhea date during the double-blind treatment period; censoring date (non-responders) = double-blind end date. Only includes participants reporting intolerable diarrhea during the open-label treatment period.

    Measured: From first dose in the Double-blind Treatment Period to Week 52

  10. Time to First Recurrence of Intolerable Diarrhea

    Time to first recurrence of intolerable diarrhea was defined as event/censored date - double-blind start date + 1, where event date (responders) = first recurrence of intolerable diarrhea date during the double-blind treatment period; censoring date (non-responders) = double-blind end date. Only includes participants reporting intolerable diarrhea during the open-label treatment period.

    Measured: From first dose in the Double-blind Treatment Period to Week 52

Timeline

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

  1. First posted29 Oct 2015 (estimated)
  2. Study start1 Nov 2015
  3. Primary completion5 Feb 2018
  4. Study completion5 Feb 2018

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590432
Sponsor's protocol ID
LIN-MD-10
Status last verified
Aug 2019
First submitted
27 Oct 2015
Last updated
22 Aug 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation, run by Forest Laboratories 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 16 inclusion and 6 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 22 Aug 2019. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 22 Aug 2019). 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?

Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum (time frame: Baseline (Day 1) up to 52 weeks or 8 months post last dose if ADA positive at Week 52 (approximately 84 weeks)). 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 NCT02590432.

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 22 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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