Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with non-constipating IBS. The study will test whether or not patients receiving AST-120 experience at least a 50% reduction in the number of days with abdominal pain compared to placebo.

Key facts

Study ID

NCT00583128

Run by

Ocera Therapeutics

People needed

117

Starts

2007-08-01

Expected to finish

2010-06-01

Last updated by the study team

2014-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body weight ≥ 40 kg;
• Recurrent abdominal pain or discomfort for three or more days per month for the last three months which meets Rome III criteria for non-constipating IBS;
• Patients on a stable diet for at least eight weeks;
• Patients ≥ 50 years of age with a negative screening colonoscopy in the last five years;
• Able and willing to comply with all protocol procedures for the planned duration of the study;
• Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information,
• Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purpose of this trial.) Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.

You may not qualify if…

• Constipating IBS;
• History of untreated lactose intolerance;
• History of colonic or major abdominal surgery (colectomy, for example);
• Active (untreated) Thyroid disease;
• Current diagnosis of major depression or psychosis;
• Known positive stool cultures for Clostridium difficile or other pathogens;
• Any condition necessitating the administration of analgesics (except paracetamol), probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics or spasmolytic medications;
• Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling;
• Other major physical or major psychiatric illness within the last six months that in the opinion of the investigator would affect the patient's ability to complete the trial;
• Uncontrolled systemic disease such as diabetes;
• Patients undergoing chemotherapy for the treatment of cancer;
• Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used;
• Participation in another study within eight (8) weeks prior to the study;
• Unable to attend all visits required by the protocol;
• Female patients must be excluded if they are pregnant, breast feeding, or planning to become pregnant during the study.

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Northern California Research — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Madeleine DuPree, MD — Boynton Beach, Florida, United States
• Michael Epstein, MD — Annapolis, Maryland, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Long Island Gastrointestinal Research Group — Great Neck, New York, United States
• LeBauer Research Associates — Greensboro, North Carolina, United States
• Peters Medical Research, LLC — High Point, North Carolina, United States
• Ohio Gastroenterology and Liver Institute — Cincinnatti, Ohio, United States
• Oklahoma Foundation for Digestive Disease — Oklahoma City, Oklahoma, United States
• Breco Research LTD — Houston, Texas, United States
• Wisconsin Center for Advanced Research — Milwaukee, Wisconsin, United States
• Zuid-Oost Limburg Campus St. Jan — Genk, Genk, Belgium
• UCL St. Luc — Woluwe, Woluwe, Belgium
• AZ St. Lucas Assebroek — Assebroek, Belgium
• UZ Leuven — Leuven, Belgium

Full record on ClinicalTrials.gov

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