Crohn's Disease
Conditions
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).
Interventions
DRUGCelebrex
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.
DRUGplacebo
placebo PO BID for either the first eight weeks or the last eight weeks of the study.
Sponsors
Shadyside Hospital Foundation
Pfizer
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment | completion of all study participants | Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment | completion of all study participants | No results or publication, data destroyed due to age of study. |
Participant flow
Recruitment details
No results or publication, data destroyed due to age of study. Enrollment number retrieved from old IRB database and not from study records and cannot be verified.
Pre-assignment details
No results or publication, data destroyed due to age of study.
Participants by arm
| Arm | Count |
|---|---|
| Celebrex Followed by Placebo either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
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 - | 0 |
| Placebo Followed by Celebrex 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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Time frame: completion of all study participants
Population: No results or publication, data destroyed due to age of study.
Secondary
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
No results or publication, data destroyed due to age of study.
Time frame: completion of all study participants