Safety of Celecoxib in Patients With Crohn's Disease

NCT00177866

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety of Celecoxib in Patients With Crohn's Disease
Official Title  ICMJE The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • 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)
  • Drug: placebo
    placebo PO BID for either the first eight weeks or the last eight weeks of the study.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Celebrex
  • 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
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 23, 2010)
28
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
60
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00177866
Other Study ID Numbers  ICMJE 0312013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • Shadyside Hospital Foundation
  • Pfizer
Investigators  ICMJE
Principal Investigator:George L Arnold, MDUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP