Clinical trial NCT02240121: One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Rifaximin
Clinical remission with endoscopic response
Inflammatory Bowel Disease
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC
First posted: 2014-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

Detailed description: RECD3125 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin DR tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate Crohn's disease.

Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).

Eligibility criteria: Major Inclusion Criteria:

* Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior to randomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).
* During the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools.

Major Exclusion Criteria:

* Pregnant or lactating females. Females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study. Diagnosis of ulcerative or indeterminate colitis.
* Diagnosis of Celiac Disease.
* Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for Crohn's disease during the study period.
* Presence of an ileostomy or colostomy.
* Known fixed symptomatic stenosis/stricture of the small or large bowel.
* Had more than one segmental colonic resection.
* Had more than 3 small bowel resections or symptoms associated with short bowel syndrome.
* Current evidence of peritonitis.
* History or evidence of colonic mucosal dysplasia.
* History or evidence of adenomatous colonic polyps that have not been removed.
* Unwilling to be tapered off corticosteroids by Week 8 or the participant is known by the Investigator to be steroid-dependent.
* Has used a biologic within 12 weeks of randomization.
* Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
* Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.

Primary outcomes:
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16
timeFrame: Week 16
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16
timeFrame: Week 16
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16
timeFrame: Week 16
measure: Number of Participants With Endoscopic Response Between Week 16 and 17
timeFrame: Baseline, Week 16 to 17
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52
timeFrame: Week 52
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52
timeFrame: Week 52
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52
timeFrame: Week 52
measure: Number of Participants With Endoscopic Response at Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16
timeFrame: Week 16
measure: Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time
timeFrame: From Baseline to Week 52
measure: Number of Participants With SES-CD Score of 0 at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Orange
country: United States
state: California
city: San Carlos
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Danbury
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Homestead
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plant City
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Urbana
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Pratt
country: United States
state: Kansas
city: Madisonville
country: United States
state: Kentucky
city: Chevy Chase
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Marlborough
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Mexico
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Marlton
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: Kinston
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Mentor
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Sayre
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Pasadena
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Leesburg
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: