Clinical trial NCT02240108: One Year Study of Rifaximin Delayed Release (DR) 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: 81
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: RECD3126 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: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Sherwood
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: La Jolla
country: United States
state: California
city: La Mirada
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Crestview Hills
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: West Monroe
country: United States
state: Louisiana
city: Hagerstown
country: United States
state: Maryland
city: Hollywood
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Caro
country: United States
state: Michigan
city: Stevensville
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Plymouth
country: United States
state: Minnesota
city: Ocean Springs
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Bridgeton
country: United States
state: Missouri
city: Creve Coeur
country: United States
state: Missouri
city: Vineland
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: Kinston
country: United States
state: North Carolina
city: Beavercreek
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Columbia
country: United States
state: South Carolina
city: Fort Mill
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Humble
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Valley City
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Richland
country: United States
state: Washington
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: