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

• ClinicalTrials.gov Identifier: NCT00720057
• Recruitment Status: Completed
• First Posted: July 22, 2008
• Results First Posted: January 25, 2011
• Last Update Posted: August 25, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Toothache	Drug: Naproxen Sodium ER (BAYH6689); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: June 2008
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: August 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Summed Pain Intensity Difference (SPID) [ Time Frame: 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 :

1. Total Pain Relief (TOTPAR) [ Time Frame: 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.
2. Summed Pain Intensity Difference at Specific Time Intervals [ Time Frame: 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.
3. Time to First Use of Rescue Medication [ Time Frame: 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.
4. Global Assessment of the Investigational Product as a Pain Reliever [ Time Frame: 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).
5. Time to Onset of Effect [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Texas

Austin, Texas, United States, 78705

Austin, Texas, United States, 78744

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 to find information about studies related to Bayer Healthcare products conducted in Europe 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: Curr Med Res Opin. 2016;32(3):611.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00720057
• Other Study ID Numbers: 13130; 2014-005269-66 ( EudraCT Number )
• First Posted: July 22, 2008
• Results First Posted: January 25, 2011
• Last Update Posted: August 25, 2015
• Last Verified: August 2015

Keywords provided by Bayer:

Dental Pain; Analgesia

Additional relevant MeSH terms:

Toothache; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action