Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain
Information source: Bayer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Toothache
Intervention: Naproxen Sodium (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Summed Pain Intensity Difference (SPID)
Secondary outcome: Total Pain Relief (TOTPAR)
Eligibility
Minimum age: 16 Years.
Maximum age: 45 Years.
Gender(s): Both.
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, NSAIDs, aspirin, any other pain reliever (OTC 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)
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Austin, Texas 78704, United States; Not yet recruiting
Austin, Texas 78705, United States; Not yet recruiting
Salt Lake City, Utah 84124, United States; Recruiting
Additional Information
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Starting date: June 2008
Ending date: September 2008
Last updated: September 24, 2008
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