NCT02757105

Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: RedHill Biopharma Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	BEKINDA
DRUG	Placebo

Timeline

• Start date: 2016-05-19
• Primary completion: 2017-06-16
• Completion: 2017-07-14
• First posted: 2016-04-29
• Last updated: 2018-08-28
• Results posted: 2018-07-31

Locations

16 sites across 1 country: United States