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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Complete Spontaneous Bowel Movement Responders vs Placebo

Timeframe: 12 weeks

Trial details

NCT IDNCT01923428

SponsorArdelyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2019-12-23

View on ClinicalTrials.gov More Constipation Predominant Irritable Bowel Syndrome trials