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Safety of Celecoxib in Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00177866
Recruitment Status : Terminated (We were unable to get additional funding to complete study.)
First Posted : September 15, 2005
Results First Posted : July 15, 2016
Last Update Posted : August 29, 2016
Sponsor:
Collaborators:
Shadyside Hospital Foundation
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: Celebrex
Drug: placebo
Enrollment 28
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.
Arm/Group Title Celebrex Followed by Placebo Placebo Followed by Celebrex
Hide Arm/Group Description

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 -

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.
Period Title: Overall Study
Started 0 [1] 0 [1]
Completed 0 [1] 0 [1]
Not Completed 0 0
[1]
No results or publication, data destroyed due to age of study.
Arm/Group Title Celebrex Followed by Placebo Placebo Followed by Celebrex Total
Hide Arm/Group Description

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 -

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. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
No results or publication, data destroyed due to age of study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
Hide Description Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment
Time Frame completion of all study participants
Hide Outcome Measure Data
Hide Analysis Population Description
No results or publication, data destroyed due to age of study.
Arm/Group Title Celebrex Followed by Placebo Placebo Followed by Celebrex
Hide Arm/Group Description:

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 -

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
Hide Description No results or publication, data destroyed due to age of study.
Time Frame completion of all study participants
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celebrex Followed by Placebo Placebo Followed by Celebrex
Hide Arm/Group Description:

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 -

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description No results or publication, data destroyed due to age of study.
 
Arm/Group Title Celebrex Followed by Placebo Placebo Followed by Celebrex
Hide Arm/Group Description

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 -

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.
All-Cause Mortality
Celebrex Followed by Placebo Placebo Followed by Celebrex
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celebrex Followed by Placebo Placebo Followed by Celebrex
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celebrex Followed by Placebo Placebo Followed by Celebrex
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George Arnold, MD
Organization: University of Pittseburgh
Phone: 412 621-2334
EMail: Arnoldgl@upmc.edu
Layout table for additonal information
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177866     History of Changes
Other Study ID Numbers: 0312013
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: June 15, 2016
Results First Posted: July 15, 2016
Last Update Posted: August 29, 2016