Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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 description: 
      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 diarrhea only when patients are experiencing at least 3 liquid or soft stools in one day.
      However, Loperamide is prohibited during the two week screening period.

      Patients will not be allowed to take the following medications whilst on trial and these
      therapies must have been discontinued by at least two weeks prior to their baseline visit:
      probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers,
      prokinetics, spasmolytics, analgesics, other investigational agents and any over-the-counter
      medications.

      Patient will be required to keep a diary during the study
    

Intervention name(s): AST-120; Celphere® CP-305
Intervention type(s): Drug; Drug
Intervention description(s): oral, sachet, 2 grams three times daily for 8 weeks; oral, placebo, sachet, 2 grams three times daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; Irritable Bowel Syndrome