Safety of Celecoxib in Patients With Crohn's Disease

The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Celebrex; Drug: placebo

Detailed Description

Please refer to brief summary (above).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment	Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment	completion of all study participants

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment	No results or publication, data destroyed due to age of study.	completion of all study participants

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Pfizer; Shadyside Hospital Foundation
• Investigators: Principal Investigator: George L Arnold, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 0312013