Induction of Clinical Response Using Rifaximin in Crohn's Disease

NCT00603616 | Completed Phase 2

• 1 other identifier: 32871
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.

Conditions

Crohn's Disease

Keywords

Inflammatory Bowel Disease; Crohn disease; Crohn's disease; Rifaximin

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI)

  8 weeks

Secondary Outcomes (5)

• Evaluate the efficacy of rifaximin compared to placebo at inducing clinical remission in CD subjects

  8 weeks

• Evaluate the safety profile of rifaximin in subjects with active CD

  16 weeks for those subjects who do not cross over, 32 weeks for those who do cross over

• Evaluate the effect rifaximin has on the quality of life in subjects with CD compared to placebo

  8 weeks

• Evaluate if there are any clinical parameters which might predict response to rifaximin

  8 weeks

• Compare mean changes in CDAI scores between rifaximin and placebo treated subjects

  8 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo pills

Drug: Placebo Comparator

2

ACTIVE COMPARATOR

Rifaximin

Drug: Rifaximin

Interventions

Placebo Comparator DRUG

Matching oral placebo pills to be taken twice daily for a total of 8 weeks

1

Rifaximin DRUG

Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks

Also known as: Xifaxan

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 to 80 years of age, inclusive, that can themselves provide written, informed consent and authorization of use of protected health information prior to any study-related procedures and who are, in the opinion of the investigator(s), likely to comply with all the requirements of the study
• Subjects must have a prior diagnosis of CD established by endoscopy and clinical parameters as determined by the investigator(s) for at least 3 months prior to randomization
• Subjects must be able to participate in all required follow-up visits and fill out all related documentation (e.g. symptom diary)
• Subjects currently with moderately active disease defined as a CDAI 250-450
• Concomitant medications:
• If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 4 weeks prior to the randomization
• If subjects are on azathioprine, 6-mercaptopurine, or methotrexate, they will have had to be on a stable dosage for at least 8 weeks
• Subjects are allowed to be on corticosteroids at a dose equivalent to 20 mg or less of prednisone, IF the dose has been stable for a minimum of 2 weeks. Steroids must be held stable throughout the induction portion of the study. The maximum dose of budesonide must not exceed 9mg per day and must also have been stable for a minimum of 2 weeks.
• No oral or intravenous antibiotics within 4 weeks prior to randomization
• No current or past use of biological treatment within 6 weeks of randomization into study (e.g. infliximab)
• If subjects have previously been on any of the above products but are no longer taking them, they should not have received any of the relevant therapeutic products within 4 weeks prior to randomization
• No other experimental or non-FDA approved medications are allowed. If the subject has previously been on an experimental therapy, they must have not received the therapy within the prior 8 weeks prior to randomization
• Subjects on concomitant medications for CD will not be allowed to change dosages during the study
• If subjects are at increased risk of colorectal cancer (defined as having an 8-year history of pan-colitis or 12 year history of left sided colitis), they will need to have undergone a colonoscopy with pan-colonic surveillance biopsies within 2 years of the screening visit. The biopsies must be negative for dysplasia
• Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the screening visit through 30 days (females) and 30 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study

You may not qualify if:

• Evidence of active infection which may include any of the following
• Febrile ( \> 38.5ºC)
• Positive blood culture within 2 weeks prior to randomization
• Evidence of toxic megacolon or abscess
• Positive stool culture for enteric pathogens, pathogenic ova or parasite, or a positive assay for C. difficile toxin at screening
• Subjects with CDAI \> 450
• Any current use or use within the last 8 weeks of an investigational drug
• Current or past use (within past 12 wks) of biological treatment
• Current or use within the last 4 weeks of any oral or intravenous antibiotic
• Anticipated increased dosage of any medication to treat CD
• Anticipated need for surgery within 12 weeks
• Known obstructive diseases of the gastrointestinal system
• Medical conditions requiring in-patient hospitalization
• Proctocolectomy, total colectomy, ileostomy, or stoma
• Severe cardiopulmonary disease:

Sponsors & Collaborators

• Scott Lee: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Scott D Lee, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: November 1, 2008
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)