Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00720057
First received: July 1, 2008
Last updated: June 4, 2012
Last verified: June 2012
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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 3 |
| 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:
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, 78744 | |
| 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:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Consumer Care L.L.C. |
| 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: | June 4, 2012 |
| 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 May 19, 2013