Safety of Celecoxib in Patients With Crohn's Disease - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Shadyside Hospital Foundation Pfizer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177866

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Celebrex Drug: placebo	Phase IV

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Crossover Assignment, Safety Study
Official Title:	The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment [ Time Frame: completion of all study participants ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores in response to treatment [ Time Frame: completion of all study participants ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks	Drug: 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.
B: Placebo Comparator either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks	Drug: placebo placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Detailed Description:

Please refer to brief summary (above).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Greater than 18 years of age or less than 70 years of age
Confirmed diagnosis of Crohn's disease
Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200).

Exclusion Criteria:

Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant)
Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications
NSAID use at time of study
Baseline moderate to severe Crohn's disease activity (CDAI > 200)
Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.
Treatment with current Crohn's medication for a period of less than 3 months
Surgery for Crohn's disease (within 1 month)
Known sensitivity to celecoxib, NSAIDs, or sulfonamides
History of gastritis, gastrointestinal bleeding, or peptic ulcer disease
Advanced kidney disease
Severe hepatic impairment
Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177866

Contacts

Contact: Mary R Beaves, BSN	412-623-1309	beavesmr@upmc.edu
Contact: George L Arnold, MD	412-621-2334	arnoldgl@upmc.edu

Locations

United States, Pennsylvania
UPMC Shadyside Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Mary R Beaves, BSN 412-623-1309 beavesmr@upmc.edu
Contact: George L Arnold, MD 412-621-2334 arnoldgl@upmc.edu
Principal Investigator: George L Arnold, MD

Sponsors and Collaborators

University of Pittsburgh

Shadyside Hospital Foundation

Pfizer

Investigators

Principal Investigator:

George L Arnold, MD

University of Pittsburgh

More Information

Responsible Party:	UPMC Shadyside ( George Louis Arnold, MD )
Study ID Numbers:	0312013
Study First Received:	September 13, 2005
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00177866
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Celecoxib
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009