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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total Pain Relief (TOTPAR) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment:	336
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
Arm 1: Experimental	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
Arm 2: Placebo Comparator	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:

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No publications provided

Responsible Party:	Bayer Consumer Care Inc ( Therapeutic Area Head )
Study ID Numbers:	13130
Study First Received:	July 1, 2008
Last Updated:	December 9, 2009
ClinicalTrials.gov Identifier:	NCT00720057 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Dental Pain
Analgesia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Tooth Diseases
Naproxen
Molecular Mechanisms of Pharmacological Action
Facial Pain
Toothache
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Gout Suppressants

Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Stomatognathic Diseases
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010