The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C) (NCT01923428) | Clinical Trial Compass
CompletedPhase 2/3
The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)
United States356 participantsStarted 2013-08
Plain-language summary
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Females and males must agree to use appropriate methods of contraception or be sterile (with appropriate documentation)
* Subject is ambulatory
* Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS with a history of \<5 SBMs per week
* Subject meets Screening eligibility criteria (see below)
* A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs (i.e., unexplained weight loss, non-hemorrhoid blood in stools)
* Ability to communicate well with the Investigator and to comply with the requirements of the entire study, including an understanding of how to use the touch-tone telephone electronic diary.
* Written informed consent and a willingness to participate in the study as it is described.
* Daily access to a touch tone telephone.
Exclusion Criteria:
* Functional diarrhea as defined by Rome III criteria
* IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening. Including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcin…
What they're measuring
1
Percent Complete Spontaneous Bowel Movement Responders vs Placebo