Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After
      qualifying for the study and signing informed consent, patients will undergo a two-week
      observation period during which stool consistency and frequency data and symptom data will be
      collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo.
      Patients will continue on treatment for 8 weeks. Each medication will be given once daily.
    

Detailed description: 
      All patients will undergo baseline evaluation including full history and physical, with
      particular attention to gastrointestinal symptomatology and findings, a standard set of
      safety laboratory examinations (CBC and platelet count, biochemical profile, urinalysis,
      serum thyroid-stimulating hormone (TSH) and free T4, INR), and 12-lead ECG. In addition, the
      following studies will be performed to exclude other causes of gastrointestinal symptoms:

        -  Serum testing for C-reactive protein and gluten sensitivity

        -  Colonoscopy if required per protocol

        -  Patients with a history of positive tests for ova, parasites or Clostridium difficile
           must undergo repeat testing, which must be negative, during the screening period.
           Starting during the baseline observation phase, all patients will keep diaries of
           symptomatology and stool frequency and consistency. Stool consistency will be assessed
           according to the Bristol Stool Form scale (Lewis and Heaton, 1997).

      Patients will keep diaries of stool frequency and consistency, symptoms, study medication
      compliance, and use of all medications, including rescue medications, throughout the study.

      Serum electrolyte assays (bicarbonate, calcium, chloride, magnesium, potassium, and sodium)
      will be performed at week 3 on study. Safety laboratory examinations will be performed during
      and after the treatment period in accordance with the study procedures schedule below.

      Patients will be questioned periodically regarding concomitant medication use and the
      occurrence of adverse events.

      Patients must complete at least 12 days of all baseline diary entries within the 14 day
      screening period to be eligible to participate in the study. Patients completing fewer than
      12 days of diary entries may, at the investigator's discretion, repeat the screening period
      diary. As long as the patent can complete and enter the study within 6 weeks, baseline
      laboratory studies need not be repeated. If repeating the 2 weeks' baseline diary will result
      in a period longer than 6 weeks from consent to start of treatment, the medical monitor must
      be consulted prior to randomization.
    

Intervention name(s): BEKINDA; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RHB-102 12 mg; Ondansetron Bimodal Release Tablet 12 mg
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment