DRUG
Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Status
Completed
Phase
Phase 3
Enrollment
1,559
Locations
118
Results
Posted
Publications
0
Study summary
What the protocol is testing.
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 3, 2008
Study start
Oct 31, 2008
Primary completion
Jan 31, 2012
Study completion
Jan 31, 2012
Results posted
Feb 15, 2019
Registry updated
Feb 15, 2019
Outcomes
What the study measures.
Primary outcomes
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame · Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have * entered study LIN-MD 01\[NCT00765882\] or LIN-MD-31 \[NCT00948818\] and at minimum completed the pre-treatment period or * completed one of the following studies: MCP-103-004 \[NCT00306748\], MCP-103-005 \[NCT00258193\], MCP-103-201 \[NCT00402337\], MCP-103-202 \[NCT00460811\] * Sexually active patients of childbearing potential agree to use birth control * Females of childbearing potential must have a negative urine pregnancy test prior to dosing * Lactating females must agree not to breastfeed * Patient must meet protocol criteria for CC or IBS-C Exclusion Criteria: * Patient must not use protocol-defined prohibited medicine * Patient is planning to receive an investigational drug at any time during the study * Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test
Study locations
118 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Innovative Clinical Trials
Birmingham, Alabama, United States
Parkway Medical Center
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Radiant Research, Inc.
Chandler, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Pivotal Research Center
Peoria, Arizona, United States
Carl T Hayden VA Medical Center GI Section-CS-111G
Phoenix, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Radiant Research, Inc.
Scottsdale, Arizona, United States
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Providence Clinical Research
Burbank, California, United States
Encompass Clinical Research North Coast
Encinitas, California, United States
Family Medical Center
Foothill Ranch, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Advanced Clinical Research Institute
Orange, California, United States
Westlake Medical Research
Westlake Village, California, United States
Boulder Medical Center, P.C.
Boulder, Colorado, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Colorado Gastroenterology, Prof LLC
Denver, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Western States Clinical Research
Wheat Ridge, Colorado, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Linaclotide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Virtual Reality and Linaclotide for IBS-C
Mayo Clinic · Irritable Bowel Syndrome With Constipation
Not applicable
Recruiting
65
2026-07
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Colorectal Adenoma · Stage 0 Colorectal Cancer AJCC v8
Phase 2
Active, not recruiting
150
2026-07
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
AbbVie · Functional Constipation (FC) · Chronic Idiopathic Constipation (CIC)
Phase 3
Completed
123
2026-05
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
University of Nottingham · Cystic Fibrosis (CF)
Early Phase 1
Recruiting
26
2026-05
GCC Agonist Signal in the Small Intestine
University of Wisconsin, Madison · Barrett Esophagus · Gastroesophageal Reflux Disease
Phase 1
Completed
43
2026-04
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
Texas Tech University Health Sciences Center, El Paso · Chronic Constipation · Diabete Mellitus
Phase 4
Active, not recruiting
23
2026-04
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Md Mehedi Shahriar · Chronic Idiopathic Constipation · Irritable Bowel Syndrome (IBS-C)
Phase 4
Not yet recruiting
90
2026-02
Linaclotide for Colonoscopy Bowel Prep
University of Florida · Patients Scheduled for Colonoscopy
Phase 1 / Phase 2
Recruiting
10
2026-01
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.