Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).
The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Irritable Bowel Syndrome With Constipation
Intervention
Linaclotide 300 micrograms, Matching placebo
Location
Forest Investigative Site 036
Birmingham
Alabama
United States
35215
Status
Completed
Source
Forest Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00948818
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:20:27-0400
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Medical and Biotech [MESH] Definitions
Colonic Diseases, Functional
Chronic or recurrent colonic disorders without an identifiable structural or biochemical explanation. The widely recognized IRRITABLE BOWEL SYNDROME falls into this category.
Irritable Bowel Syndrome
A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.
Bifidobacterium Longum Subspecies Infantis
A subspecies of Bifidobacterium longum that occurs in the GASTROINTESTINAL TRACT of human infants and is used as a PROBIOTIC. It may also be used in the treatment of IRRITABLE BOWEL SYNDROME.
Short Bowel Syndrome
A malabsorption syndrome resulting from extensive operative resection of the SMALL INTESTINE, the absorptive region of the GASTROINTESTINAL TRACT.
Anticholinergic Syndrome
Adverse drug effects associated with CHOLINERGIC ANTAGONISTS. Clinical features include TACHYCARDIA; HYPERTHERMIA; MYDRIASIS, dry skin and dry mucous membranes, decreased bowel sounds and urinary retention in peripheral anticholinergic syndrome; and HALLUCINATIONS; PSYCHOSES; SEIZURES; and COMA in central anticholinergic syndrome.
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