Back to resultsA Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen Sodium (Aleve, BAY117031)
Ibuprofen (Advil)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Postsurgical pain
Eligibility Criteria
Inclusion Criteria:
- Healthy, ambulatory, male or female volunteers 16-40 years of age;
- Body mass index 18.0 to 30.0 kg/m^2 inclusive;
- Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
- Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;
Exclusion Criteria:
- History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Naproxen Sodium (Aleve, BAY117031)
Ibuprofen (Advil)
Placebo
Arm Description
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
Outcomes
Primary Outcome Measures
Time to First Use of Rescue Medication
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Secondary Outcome Measures
Sum of Pain Intensity Difference (SPID)
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Total Pain Relief (TOTPAR)
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03404206
Brief Title
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postsurgical pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen Sodium (Aleve, BAY117031)
Arm Type
Experimental
Arm Description
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
Arm Title
Ibuprofen (Advil)
Arm Type
Active Comparator
Arm Description
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
Intervention Type
Drug
Intervention Name(s)
Naproxen Sodium (Aleve, BAY117031)
Intervention Description
220 mg x 2 tablets, oral, single dose
Intervention Type
Drug
Intervention Name(s)
Ibuprofen (Advil)
Intervention Description
200 mg x 2 tablets, oral, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo, 2 tablets, oral, single dose
Primary Outcome Measure Information:
Title
Time to First Use of Rescue Medication
Description
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID)
Description
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Time Frame
Up to 24 hours
Title
Total Pain Relief (TOTPAR)
Description
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were 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.
Time Frame
Up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy, ambulatory, male or female volunteers 16-40 years of age;
Body mass index 18.0 to 30.0 kg/m^2 inclusive;
Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;
Exclusion Criteria:
History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31402718
Citation
Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
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