Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01543178
Other study ID # RFIB3053
Secondary ID
Status Completed
Phase Phase 3
First received February 27, 2012
Last updated December 8, 2017
Start date February 2012
Est. completion date June 2014

Study information

Verified date December 2017
Source Valeant Pharmaceuticals International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.


Description:

It is important in chronic conditions to have information about how a product that is intended for short course administration in order to confer prolonged benefit should be administered beyond the first cycle of use once symptoms reappear. This Phase 3 study will evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg three times daily (TID) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin 550 mg TID for 14 days.

This study consists of several treatment phases outlined below:

Screening/Treatment 1 Phase. Subjects will receive single-blind placebo TID for 7-13 days and answer daily IBS symptom-related questions.

Treatment 2 Phase. Eligible subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1. Nonresponders will withdraw from the study.

Maintenance Phase 1. Subjects will continue the treatment-free follow-up period for up to 18 weeks until either: 1) they experience recurrence or 2) enrollment is met in the Treatment 3 Phase (Double Blind Repeat Treatment Phase). Subjects who do not meet recurrence criteria by the end of the Maintenance Phase 1 will withdraw from the study.

Treatment 3 Phase/ Double Blind Repeat Treatment Phase. Subjects who meet criteria for recurrence will be randomized 1:1 to receive either rifaximin 550 mg TID or placebo TID for 2 weeks with a 4-week treatment-free follow-up.

Primary efficacy analysis will be performed at the end of the Treatment 3 Phase (at Week 6 of the double-blind period).

Maintenance Phase 2. All subjects continued into an additional treatment-free follow-up period of up to 6 weeks (Maintenance Phase 2).

Treatment 4 Phase/Second Repeat Treatment Phase. Subjects will receive the same double-blind treatment as previously assigned in the Treatment 3 Phase for 2 weeks with a 4-week treatment-free follow-up.

A lactulose breath test sub-study will be conducted at select sites.


Recruitment information / eligibility

Status Completed
Enrollment 2583
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS confirmed by Rome III diagnostic criteria.

- At least 18 years of age.

- Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if < 50 years of age or previous colonoscopy > 10 years prior.

- Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.

Exclusion Criteria:

- Diabetes (Type 1 or 2).

- Lactose intolerance and not controlled by a lactose-free diet.

- Pregnant or planning to become pregnant or is lactating.

- History of HIV or hepatitis B or C.

- Participation in investigational study within past 30 days.

- Taking rifaximin or any other antibiotic within past 60 days.

- Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.

- History of GI surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
open-label rifaximin
550 mg three times a day (open-label)
double-blind placebo
3 times a day (double-blind)
double-blind rifaximin
550 mg three times a day (double-blind)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Repeat Treatment Responders Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea. 4-week treatment-free follow-up in double-blind repeat treatment phase.
See also
  Status Clinical Trial Phase
Completed NCT00552565 - Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT04950296 - To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome N/A
Completed NCT02959983 - Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use Phase 4
Withdrawn NCT02320318 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT01303224 - Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D) Phase 2
Recruiting NCT05646186 - Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome N/A
Recruiting NCT03806959 - Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy N/A
Completed NCT04129619 - A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 2
Recruiting NCT04855799 - GI Permeability Change in Response to Aquamin® Phase 2
Completed NCT04662957 - Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome N/A
Completed NCT04557215 - Efficacy and Safety of Rifaximin With NAC in IBS-D Phase 1/Phase 2
Enrolling by invitation NCT05311293 - Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
Completed NCT05277428 - Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1 N/A
Not yet recruiting NCT03221790 - Effect of FODMAPs on Mucosal Inflammation in IBS Patients N/A
Completed NCT03557788 - Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome Phase 4
Completed 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) Phase 2
Enrolling by invitation NCT06432569 - Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1) N/A
Recruiting NCT04830410 - The Effects of Carbohydrates in Irritable Bowel Syndrome N/A
Completed NCT03245645 - FODMAP Reintroduction in Irritable Bowel Syndrome N/A
Terminated NCT02120027 - 52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3