Study Comparing the Efficacy of Two Ibuprofen Formulations

This study has been completed.

Study NCT00740857 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on August 22, 2008. Last Updated on June 1, 2011 History of Changes

Results First Received: October 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Pain
Interventions:	Drug: placebo Drug: ibuprofen Formulation 1 Drug: ibuprofen Formulation 2

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in the United States from August 2008 to October 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient’s eligibility. Surgery occurred within 14 days of the screening visit.

Reporting Groups

	Description
Placebo	2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
Ibuprofen Formulation 1	2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
Ibuprofen Formulation 2	2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery

Participant Flow: Overall Study

	Placebo	Ibuprofen Formulation 1	Ibuprofen Formulation 2
STARTED	33	88	90
COMPLETED	32	88	90
NOT COMPLETED	1	0	0
Withdrawal by Subject	1	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
Ibuprofen Formulation 1	2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
Ibuprofen Formulation 2	2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery

Baseline Measures

	Placebo	Ibuprofen Formulation 1	Ibuprofen Formulation 2	Total
Number of Participants [units: participants]	33	88	90	211
Age [units: years] Mean ± Standard Deviation	18.8 ± 2.7	18.5 ± 2.5	19.0 ± 3.0	18.8 ± 2.7
Gender [units: participants]
Female	16	43	45	104
Male	17	45	45	107

Outcome Measures

Show All Outcome Measures

1. Primary:

Time to Meaningful Pain Relief [ Time Frame: 0-6 hours ]

Show Outcome Measure 1

2. Secondary:

Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ]

Show Outcome Measure 2

3. Secondary:

Pain Relief (PR) Scores at Individual Time Points [ Time Frame: 0-6 hours ]

Show Outcome Measure 3

4. Secondary:

Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]

Show Outcome Measure 4

5. Secondary:

Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points [ Time Frame: 0-6 hours ]

Show Outcome Measure 5

6. Secondary:

Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]

Show Outcome Measure 6

7. Secondary:

Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]

Show Outcome Measure 7

8. Secondary:

Time to First Perceptible Relief [ Time Frame: 0-6 hours ]

Show Outcome Measure 8

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: The PI agreed to allow the sponsor 30 days to review and approve abstracts and 60 days to review and approve manuscripts prior to submission to protect against disclosure of confidential information.

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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00740857 History of Changes
Other Study ID Numbers:	PV-08-24
Study First Received:	August 22, 2008
Results First Received:	October 30, 2009
Last Updated:	June 1, 2011
Health Authority:	United States: Institutional Review Board