Safety of Celecoxib in Patients With Crohn's Disease

NCT ID: NCT00177866

Last Updated: 2016-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2010-06-30

Brief Summary

The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn's disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn's disease and experience chronic pain from arthritis and arthralgia.

Detailed Description

Please refer to brief summary (above).

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A Placebo or Celebrex

either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks

Group Type: ACTIVE_COMPARATOR

Celebrex

Intervention Type: DRUG

Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.

B Placebo or Celebrex

either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Interventions

Celebrex

Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.

Intervention Type: DRUG

placebo

placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Intervention Type: DRUG

Other Intervention Names

Celecoxib (brand name)

Eligibility Criteria

Inclusion Criteria

1. Greater than 18 years of age or less than 70 years of age

2. Confirmed diagnosis of Crohn's disease

3. Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200).

Exclusion Criteria

1. Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant)

2. Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications

3. NSAID use at time of study

4. Baseline moderate to severe Crohn's disease activity (CDAI > 200)

5. Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.

6. Treatment with current Crohn's medication for a period of less than 3 months

7. Surgery for Crohn's disease (within 1 month)

8. Known sensitivity to celecoxib, NSAIDs, or sulfonamides

9. History of gastritis, gastrointestinal bleeding, or peptic ulcer disease

10. Advanced kidney disease

11. Severe hepatic impairment

12. Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shadyside Hospital Foundation

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George L Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Other Identifiers

0312013

Identifier Type: -

Identifier Source: org_study_id