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

Sponsor:	University of Pittsburgh
Collaborators:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Celecoxib

U.S. FDA Resources

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 ]

Enrollment:	28
Study Start Date:	December 2003
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Placebo or Celebrex 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. Other Name: Celecoxib (brand name)
Placebo Comparator: B Placebo or Celebrex 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

Sponsors and Collaborators

University of Pittsburgh

Shadyside Hospital Foundation

Pfizer

Investigators

Principal Investigator:

George L Arnold, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	George Louis Arnold, MD, UPMC Shadyside
ClinicalTrials.gov Identifier:	NCT00177866 History of Changes
Other Study ID Numbers:	0312013
Study First Received:	September 13, 2005
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012