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We were unable to get additional funding to complete study.
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| Name | Class |
|---|---|
| Shadyside Hospital Foundation | OTHER |
| Pfizer | INDUSTRY |
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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.
Please refer to brief summary (above).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Placebo or Celebrex | Active Comparator | either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks |
|
| B Placebo or Celebrex | Placebo Comparator | either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celebrex | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George L Arnold, MD | University of Pittsburgh | Principal Investigator |
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No results or publication, data destroyed due to age of study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 - |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No results or publication, data destroyed due to age of study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 - |
| BG001 | Placebo Followed by Celebrex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | No results or publication, data destroyed due to age of study. | Posted | completion of all study participants |
|
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No results or publication, data destroyed due to age of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 - |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Arnold, MD | University of Pittseburgh | 412 621-2334 | Arnoldgl@upmc.edu |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
|
| placebo | Drug | placebo PO BID for either the first eight weeks or the last eight weeks of the study. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | completion of all study participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 |
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| D007410 | Intestinal Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |