Clinical trial NCT00720057: Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Toothache
Keywords: Dental Pain
Analgesia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 312
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Summed Pain Intensity Difference (SPID)
timeFrame: 0 to 24 hours post dose
Secondary outcomes:
measure: Total Pain Relief (TOTPAR)
timeFrame: 0-24 hours post dose
measure: Summed Pain Intensity Difference at Specific Time Intervals
timeFrame: 0-16 hours post dose
measure: Time to First Use of Rescue Medication
timeFrame: postdose to first use of rescue medication
measure: Global Assessment of the Investigational Product as a Pain Reliever
timeFrame: at 24 hours postdose or immediately before first use of rescue medication
measure: Time to Onset of Effect
timeFrame: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.