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Trial record 1 of 1 for:    NCT03573908
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A Trial of Linaclotide 290 μg 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: NCT03573908
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Allergan Sales, LLC
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief 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 irritable bowel syndrome with constipation (IBS-C).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Drug: Linaclotide Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Linaclotide 290 µg
Participants received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period. At Week 12 participants were rerandomized to receive either linaclotide 290 µg or placebo for 4 weeks in the Randomized Withdrawal (RW) Period.
Drug: Linaclotide
Oral capsule
Other Name: Linzess

Placebo Comparator: Placebo
Participants received placebo to linaclotide orally once daily for 12 weeks during the Treatment Period. At Week 12 participants were switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.
Drug: Linaclotide
Oral capsule
Other Name: Linzess

Drug: Placebo
Matching placebo oral capsule




Primary Outcome Measures :
  1. Change from Baseline in Abdominal Score (abdominal bloating, abdominal discomfort, and abdominal pain) at Each Week [ Time Frame: Baseline, Weeks 1-12 ]

Secondary Outcome Measures :
  1. Change from Baseline in 12-week Abdominal Score [ Time Frame: Baseline, Week 12 ]
  2. Number of 6/12 Week Abdominal Score Responder [ Time Frame: Weeks 1-12 ]
  3. Change From Baseline in Abdominal Score at Each Week (Time Course Analysis) [ Time Frame: Baseline, Weeks 1-12 ]


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 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

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): NCT03573908


Locations
Show Show 79 study locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Allergan Sales, LLC
Investigators
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Study Chair: Wilmin Bartolini, PhD Ironwood Pharmaceuticals, Inc.
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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03573908    
Other Study ID Numbers: MCP-103-312
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
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