Bunionectomy Study - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Acute Pain
Interventions:	Drug: pregabalin Drug: naproxen sodium Drug: Comparator: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient Entered: 25 July 2007 Last Patient Last Visit: 28 January 2008 1 site

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First Patient Entered: 25 July 2007

Last Patient Last Visit: 28 January 2008

1 site

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Pregabalin 300 mg	Active Comparator: Arm 1: Pregabalin 300 mg Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Naproxen Sodium 550 mg	Active Comparator: Arm 2: Naproxen sodium 550 mg Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0.
Placebo	Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Description

Pregabalin 300 mg

Active Comparator: Arm 1: Pregabalin 300 mg

Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Naproxen Sodium 550 mg

Active Comparator: Arm 2: Naproxen sodium 550 mg

Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0.

Placebo

Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Participant Flow: Overall Study

	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo
STARTED	36	34	30
COMPLETED	32	29	28
NOT COMPLETED	4	5	2
Dosing Error	1	0	0
Incomplete Data	0	2	0
Protocol Violation	3	2	1
Early Termination	0	1	1

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin 300 mg	Active Comparator: Arm 1: Pregabalin 300 mg Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Naproxen Sodium 550 mg	Active Comparator: Arm 2: Naproxen sodium 550 mg Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0.
Placebo	Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Description

Pregabalin 300 mg

Active Comparator: Arm 1: Pregabalin 300 mg

Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Naproxen Sodium 550 mg

Active Comparator: Arm 2: Naproxen sodium 550 mg

Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0.

Placebo

Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Baseline Measures

	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Number of Participants [units: participants]	32	29	28	89
Age [units: years] Mean ± Standard Deviation	40.3 ± 14.1	40.6 ± 13.5	38.8 ± 11.6	39.9 ± 13.1
Gender [units: participants]
Female	27	23	23	73
Male	5	6	5	16
Body Weight [units: Kilograms] Mean ± Standard Deviation	72.3 ± 18.1	76.7 ± 17.2	77.2 ± 16.9	75.3 ± 17.4
Lidocaine Use ^[1] [units: Milliliters] Mean ± Standard Deviation	15.0 ± 2.3	15.9 ± 2.7	14.6 ± 1.6	15.2 ± 2.2
Propofol Use [units: Milligrams] Mean ± Standard Deviation	348.4 ± 132.9	364.5 ± 122.8	353.9 ± 105.8	355.4 ± 121.1

[1]	Regional anesthesia required during surgery

Outcome Measures

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1. Primary:

Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery [ Time Frame: First 24 hours following surgery ]

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2. Secondary:

Time to First Request of PCA Hydromorphone [ Time Frame: First 24 hours following surgery ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00601458 History of Changes
Other Study ID Numbers:	2007_661, 063
Study First Received:	January 15, 2008
Results First Received:	December 23, 2009
Last Updated:	April 13, 2010
Health Authority:	United States: Food and Drug Administration