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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

Brief 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.

Detailed Summary:

Patients experiencing non-constipating IBS will be randomized to one of two arms in the study: the experimental drug AST-120 or placebo. Patients will take 2g of AST-120 or placebo three times per day for eight weeks. After the 8 week course, patients will receive an additional 8 weeks single blind treatment, after a one week washout period.

The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305 stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations. Both are tasteless. To take the product, patients will tear open the sachet, drop the contents directly on their tongue and wash it down with 8 ounces of water.

Patients will be expected to participate in up to 10 visits, approximately three by telephone and the remainder of visits are in-clinic. At these visits, patients will undergo a number of tests including: hematology panel, lactose intolerance testing, physical exams, pregnancy tests, evaluations based on the following scales: The Bristol Stool Scale, IBS Severity Scale, IBS Quality of Life, SCL-90R.

Provided the patient has been stable for eight weeks prior to their baseline visit, they will be allowed to take the following medications: drugs that inhibit gastric secretion (histamine blockers, proton pump inhibitors), benzodiazepines and Imidazopyridines (short acting, nonbenzodiazepine hypnotics) for sleep (dose must be consistent with the use of a sleep agent) aspirin at a cardiovascular prophylactic dose (75-150 mg/day) and paracetamol. Antidepressants for non-IBS symptoms are allowed. Loperamide will be permitted as a rescue for d
Sponsor: Ocera Therapeutics

Current Primary Outcome:

  • Percent of patients who achieve at least a 50% reduction in the number of days with abdominal pain during the final 2 weeks of the double-blind treatment course. [ Time Frame: Eight weeks ]
  • Safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course. [ Time Frame: 8 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change in the IBS QOL score. [ Time Frame: Eight weeks ]
  • Percent change in HADS score. [ Time Frame: 8 weeks ]
  • Percent change in Bristol Scale score. [ Time Frame: 8 weeks ]
  • Percent change in individual items in the IBS Symptom Severity questionnaire. [ Time Frame: 8 weeks ]
  • Durability of effect after the first eight weeks of treatment. [ Time Frame: 8 weeks ]
  • Change in clinical laboratory tests from Baseline to Week 8 and to Week 18. [ Time Frame: 8 weeks ]
  • Any adverse event occurring after Week 8. [ Time Frame: 8 weeks ]
  • Physical examinations, vital signs (blood pressure, heart rate, respiration and temperature). [ Time Frame: 8 weeks ]


Original Secondary Outcome: Same as current

Information By: Ocera Therapeutics

Dates:
Date Received: December 20, 2007
Date Started: August 2007
Date Completion:
Last Updated: June 2, 2014
Last Verified: June 2014