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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.