A Phase 3 interventional study of open-label rifaximin and double-blind placebo in Irritable Bowel Syndrome With Diarrhea, sponsored by Bausch Health Americas, Inc.. Completed at 296 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 2,583 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 (treatment free). Nonresponders will withdraw from the study. Subjects who meet criteria for recurrence in Maintenance Phase 1 enter the double-blind period and are randomized 1:1 to receive rifaximin 550 mg or placebo.
Drug: open-label rifaximin
Subjects in this arm receive rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
Drug: open-label rifaximin · Drug: double-blind rifaximin
Subjects in this arm receive placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with placebo TID for 2 weeks with a 4-week treatment-free follow-up.
Drug: open-label rifaximin · Drug: double-blind placebo
550 mg three times a day (open-label)
Also known as: rifaximin
3 times a day (double-blind)
Also known as: Placebo
550 mg three times a day (double-blind)
Also known as: rifaximin
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.
Time frame: 4-week treatment-free follow-up in double-blind repeat treatment phase.
| Milestone | Open-label Rifaximin | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) |
|---|---|---|---|
| Started | 2583 | 0 | 0 |
| Completed | 636 | 0 | 0 |
| Not completed | 1947 | 0 | 0 |
| Milestone | Open-label Rifaximin | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) |
|---|---|---|---|
| Started | 0 | 328 | 308 |
| Completed | 0 | 284 | 271 |
| Not completed | 0 | 44 | 37 |
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.
| percentage of patients | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) |
|---|---|---|
| Repeat Treatment Responders | 32.6 | 25.0 |
Collected over Up to 24 weeks for the open-label period. Up to 18 weeks for the double-blind period.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Open-label Experience | — | 28/2,579 (1.1%) | 198/2,579 (7.7%) |
| Double-blind Retreatment Experience - Rifaximin Group | — | 4/328 (1.2%) | 74/328 (22.6%) |
| Double-blind Retreatment Experience - Placebo Group | — | 4/308 (1.3%) | 69/308 (22.4%) |
| Event | Total Open-label Experience | Double-blind Retreatment Experience - Rifaximin Group | Double-blind Retreatment Experience - Placebo Group |
|---|---|---|---|
| Transient ischaemic attackNervous system disorders | 1/2579 | 0/328 | 2/308 |
| Coronary artery occlusionCardiac disorders | 0/2579 | 0/328 | 1/308 |
| Non-cardiac chest painGeneral disorders | 4/2579 | 0/328 | 1/308 |
| CellulitisInfections and infestations | 1/2579 | 0/328 | 1/308 |
| HypertensionVascular disorders | 1/2579 | 0/328 | 1/308 |
| Clostridium difficile colitisInfections and infestations | 0/2579 | 1/328 | 0/308 |
| FallInjury, poisoning and procedural complications | 0/2579 | 1/328 | 0/308 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/2579 | 1/328 | 0/308 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/2579 | 1/328 | 0/308 |
| Rectal haemorrhageGastrointestinal disorders | 2/2579 | 0/328 | 0/308 |
| Event | Total Open-label Experience | Double-blind Retreatment Experience - Rifaximin Group | Double-blind Retreatment Experience - Placebo Group |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 35/2579 | 11/328 | 15/308 |
| NauseaGastrointestinal disorders | 52/2579 | 12/328 | 7/308 |
| Upper respiratory tract infectionInfections and infestations | 41/2579 | 12/328 | 8/308 |
| NasopharyngitisInfections and infestations | 36/2579 | 10/328 | 9/308 |
| HeadacheNervous system disorders | 42/2579 | 4/328 | 9/308 |
| BronchitisInfections and infestations | 15/2579 | 9/328 | 5/308 |
| Alanine aminotransferase increasedInvestigations | 24/2579 | 9/328 | 4/308 |
| Blood creatine phosphokinase increasedInvestigations | 31/2579 | 9/328 | 3/308 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/2579 | 3/328 | 8/308 |
| SinusitisInfections and infestations | 34/2579 | 7/328 | 7/308 |
Baseline results were summarized for the safety population, defined as patients who received at least 1 dose of study drug. Results are presented for patients in the open-label period only (1943) and for patients who eventually were randomized to rifaximin (329) or placebo (308) (ie, participated in both open-label and double-blind periods).
| Age, Categorical(Participants) | Open-label Rifaximin Only | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) | Total |
|---|---|---|---|---|
| <=18 years | 8 | 0 | 1 | 9 |
| Between 18 and 65 years | 1763 | 289 | 278 | 2330 |
| >=65 years | 172 | 39 | 29 | 240 |
| Age, Continuous(years) | Open-label Rifaximin Only | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) | Total |
|---|---|---|---|---|
| Mean | 46.3 ± 13.5 | 47.9 ± 14.2 | 45.6 ± 13.8 | 46.4 ± 13.7 |
| Sex: Female, Male(Participants) | Open-label Rifaximin Only | Double-blind Rifaximin (Retreatment) | Double-blind Placebo (Retreatment) | Total |
|---|---|---|---|---|
| Female | 1319 | 222 | 219 | 1760 |
| Male | 624 | 106 | 89 | 819 |
Showing the first 100 of 296 sites across 3 countries.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bausch Health Americas, Inc.