NCT03099785

Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D

A Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled, Proof of Concept Study of Efficacy and Safety of Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Cosmo Technologies Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered two to three times daily.

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Rifamycin SV 600mg t.i.d.	Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet
DRUG	Rifamycin SV b.i.d. + Placebo	Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet
DRUG	Placebo t.i.d.	Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet

Timeline

• Start date: 2017-12-18
• Primary completion: 2020-09-11
• Completion: 2020-12-14
• First posted: 2017-04-04
• Last updated: 2021-01-08

Locations

29 sites across 4 countries: Belgium, Germany, Italy, Spain