MedDataX Logo

Trial Outcomes & Findings for Safety of Celecoxib in Patients With Crohn's Disease (NCT NCT00177866)

NCT ID: NCT00177866

Last Updated: 2016-08-29

Results Overview

Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

completion of all study participants

Results posted on

2016-08-29

Participant Flow

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.

No results or publication, data destroyed due to age of study.

Participant milestones

Participant milestones
Measure
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 -
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.
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Celecoxib in Patients With Crohn's Disease

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: completion of all study participants

Population: No results or publication, data destroyed due to age of study.

Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: completion of all study participants

No results or publication, data destroyed due to age of study.

Outcome measures

Outcome data not reported

Adverse Events

Celebrex Followed by Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Followed by Celebrex

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George Arnold, MD

University of Pittseburgh

Phone: 412 621-2334

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place