Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain. - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00720057

Purpose

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

Condition	Intervention	Phase
Toothache	Drug: Naproxen Sodium ER (BAYH6689) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Summed Pain Intensity Difference (SPID) [ Time Frame: 0 to 24 hours post dose ] [ Designated as safety issue: No ]
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:

Total Pain Relief (TOTPAR) [ Time Frame: 0-24 hours post dose ] [ Designated as safety issue: No ]
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.
Summed Pain Intensity Difference at Specific Time Intervals [ Time Frame: 0-16 hours post dose ] [ Designated as safety issue: No ]
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.
Time to First Use of Rescue Medication [ Time Frame: postdose to first use of rescue medication ] [ Designated as safety issue: No ]
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.
Global Assessment of the Investigational Product as a Pain Reliever [ Time Frame: at 24 hours postdose or immediately before first use of rescue medication ] [ Designated as safety issue: No ]
Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).
Time to Onset of Effect [ Time Frame: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours ] [ Designated as safety issue: No ]
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.

Enrollment:	312
Study Start Date:	June 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Naproxen Sodium ER (BAYH6689) Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery
Placebo Comparator: Placebo Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Drug: Placebo Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720057

Locations

United States, Texas

Austin, Texas, United States, 78704

Austin, Texas, United States, 78705
United States, Utah

Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

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

Keywords provided by Bayer:

Dental Pain
Analgesia

Additional relevant MeSH terms:

Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Analgesics
Naproxen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012