Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

This study has been completed.

Study NCT00139776 Information provided by Pfizer

First Received: August 29, 2005 Last Updated: June 24, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Osteoarthritis, Knee Osteoarthritis, Hip
Intervention:	Drug: Celecoxib

Participant Flow

Show Participant Flow

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Baseline Measures

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use	Total
Number of Participants [units: participants]	431	427	858
Age [units: years] Mean ± Standard Deviation	58.5 ± 10.00	58.7 ± 9.6	58.6 ± 9.8
Gender [units: participants]
Female	317	303	620
Male	114	124	238

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Flare Events Per Time of Exposure to Study Medication [ Period III (22 weeks) ]

Show Outcome Measure 1

2. Secondary:

Time to Occurrence of First Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 2

3. Secondary:

Proportion of Days Free From Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 3

4. Secondary:

Proportion of Days in Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 4

5. Secondary:

Arthritis Pain Numerical Rating Scale (NRS) [ Period III ]

Show Outcome Measure 5

6. Secondary:

Patient's Global Assessment of Arthritis [ Period III ]

Show Outcome Measure 6

7. Secondary:

Physician's Global Assessment of Arthritis at Final Visit [ Period III (22 weeks) ]

Show Outcome Measure 7

8. Secondary:

Total Rescue Medication Taken (Mean) [ Period III (22 weeks) ]

Show Outcome Measure 8

9. Secondary:

Proportion of Days on Rescue Medication [ Period III (22 weeks) ]

Show Outcome Measure 9

10. Secondary:

Days on Flare Medication [ Period III (22 weeks) ]

Show Outcome Measure 10

11. Secondary:

Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ]

Show Outcome Measure 11

12. Secondary:

Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ]

Show Outcome Measure 12

13. Other Pre-specified:

Change in Medical Outcomes Study Sleep Scale - All Assessments [ Period III ]

Show Outcome Measure 13

14. Other Pre-specified:

Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep [ Period III ]

Show Outcome Measure 14

15. Other Pre-specified:

Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments [ Period III ]

Show Outcome Measure 15

16. Other Pre-specified:

Serious Adverse Events in Open Label run-in Period [ 2 weeks prior to double blind dosing ]

Show Outcome Measure 16

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191173
Study First Received:	August 29, 2005
Results First Received:	February 20, 2009
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00139776 History of Changes
Health Authority:	United States: Food and Drug Administration