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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02559206
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:
The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Drug: Linaclotide Drug: Matching Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation
Actual Study Start Date : October 22, 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: 30 μg linaclotide DR1 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 100 μg linaclotide DR1 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 300 μg linaclotide DR1 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 30 μg linaclotide DR2 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 100 μg linaclotide DR2 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 300 μg linaclotide DR2 and placebo Drug: Linaclotide
Oral, once daily

Experimental: 290 μg linaclotide IR and placebo Drug: Linaclotide
Oral, once daily

Placebo Comparator: Placebo Drug: Matching Placebo
Oral, once daily




Primary Outcome Measures :
  1. Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo [ Time Frame: Baseline, up to Week 12 ]
    Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.

  2. Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo [ Time Frame: Baseline, up to Week 12 ]
    Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.

  3. Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo [ Time Frame: Baseline, up to Week 12 ]
    A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.

  4. Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo [ Time Frame: Baseline, up to Week 12 ]
    A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.

  5. Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo [ Time Frame: up to Week 12 ]

    A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.

    • Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.
    • Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.
    • Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.

    A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.


  6. Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo [ Time Frame: up to Week 12 ]

    A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.

    • Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.
    • Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.
    • Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.

    A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
  • Patient has no clinically significant findings on a physical examination and clinical laboratory tests
  • Patient meets protocol criteria for diagnosis of IBS-C
  • Patient demonstrates continued IBS-C 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559206


Locations
Show Show 71 study locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Forest Laboratories
Investigators
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Study Chair: Paul Chamberlin, MD Ironwood Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Ironwood Pharmaceuticals, Inc.:
Statistical Analysis Plan  [PDF] October 4, 2016
Study Protocol  [PDF] October 9, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02559206    
Other Study ID Numbers: MCP-103-204
First Posted: September 24, 2015    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents