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

Phase 3

Completed

• Conditions: Toothache
• Interventions: Drug: Naproxen Sodium ER (BAYH6689); Drug: Placebo

• Registration Number: NCT00720057
• Lead Sponsor: Bayer

Brief Summary

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2009-12-09
• Disposition First Submitted QC: 2009-12-09
• Disposition First Posted: 2009-12-10
• Results First Submitted: 2011-01-03
• Results First Submitted QC: 2011-01-03
• Results First Posted: 2011-01-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Healthy, ambulatory, male and female volunteers between 16 to 45
• Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction
• No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery
• Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale

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Exclusion Criteria

• History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies
• Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study
• Current or past history of bleeding disorder(s)
• History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Summed Pain Intensity Difference (SPID)	0 to 24 hours post dose	Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.

Secondary Outcome Measures

Name	Time	Method
Summed Pain Intensity Difference at Specific Time Intervals	0-16 hours post dose	Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.
Global Assessment of the Investigational Product as a Pain Reliever	at 24 hours postdose or immediately before first use of rescue medication	Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).
Time to First Use of Rescue Medication	postdose to first use of rescue medication	Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.
Time to Onset of Effect	from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours	Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.
Total Pain Relief (TOTPAR)	0-24 hours post dose	Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.