Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

This study has been completed.

Study NCT00720057 Information provided by Bayer

First Received on July 1, 2008. Last Updated on April 27, 2011 History of Changes

Results First Received: January 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Toothache
Interventions:	Drug: Naproxen Sodium ER (BAYH6689) Drug: Placebo

Participant Flow

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Recruitment Details

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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Screening Period occurred up to 28 days prior to the day of dental surgery. A total of 447 subjects were screened, of which 135 were excluded (72 did not meet inclusion criteria, 19 refused to participate, 44 other reasons); 312 subjects were randomized and included in the intent-to-treat (ITT) population for efficacy and safety analysis.

Reporting Groups

	Description
Naproxen Sodium ER (BAYH6689)	single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Placebo	single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Participant Flow: Overall Study

	Naproxen Sodium ER (BAYH6689)	Placebo
STARTED	153	159
COMPLETED	152	156
NOT COMPLETED	1	3
Lost to Follow-up	0	2
Protocol Violation	1	0
Withdrawal by Subject	0	1

Baseline Characteristics

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Reporting Groups

	Description
Naproxen Sodium ER (BAYH6689)	single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Placebo	single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Baseline Measures

	Naproxen Sodium ER (BAYH6689)	Placebo	Total
Number of Participants [units: participants]	153	159	312
Age [units: years] Mean ± Standard Deviation	20.8 ± 4.03	20.4 ± 4.31	20.6 ± 4.17
Gender [units: participants]
Female	89	106	195
Male	64	53	117
Baseline Pain Intensity by Categorical Scale ^[1] [units: participants]
Moderate	99	103	202
Severe	54	56	110
Baseline Pain Intensity by Visual Analog Scale ^[2] [units: scores on a scale] Mean ± Standard Deviation	72.3 ± 13.13	72.6 ± 11.91	72.4 ± 12.51

[1]	Categorical scale: No Pain (0), Mild Pain (1), Moderate Pain (2), Severe Pain (3).
[2]	Visual Analog Scale 0-100 mm: 0 is no pain and 100 is worse possible pain.

Outcome Measures

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1. Primary:

Summed Pain Intensity Difference (SPID) [ Time Frame: 0 to 24 hours post dose ]

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2. Secondary:

Total Pain Relief (TOTPAR) [ Time Frame: 0-24 hours post dose ]

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3. Secondary:

Summed Pain Intensity Difference at Specific Time Intervals [ Time Frame: 0-16 hours post dose ]

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4. Secondary:

Time to First Use of Rescue Medication [ Time Frame: postdose to first use of rescue medication ]

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5. Secondary:

Global Assessment of the Investigational Product as a Pain Reliever [ Time Frame: at 24 hours postdose or immediately before first use of rescue medication ]

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6. Secondary:

Time to Onset of Effect [ Time Frame: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours ]

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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.

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
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Consumer Care Inc
ClinicalTrials.gov Identifier:	NCT00720057 History of Changes
Other Study ID Numbers:	13130
Study First Received:	July 1, 2008
Results First Received:	January 3, 2011
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration