Safety of Celecoxib in Patients With Crohn's Disease

This study has been terminated.
(We were unable to get additional funding to complete study.)
Sponsor:
Collaborators:
Shadyside Hospital Foundation
Pfizer
Information provided by (Responsible Party):
Mary Beaves, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177866
First received: September 13, 2005
Last updated: May 21, 2014
Last verified: May 2014
  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 4

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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Mary Beaves, Clinical Research Coordinator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177866     History of Changes
Other Study ID Numbers: 0312013
Study First Received: September 13, 2005
Last Updated: May 21, 2014
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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014