check_circleStudy Completed
Pain, Postoperative
Bayer Identifier:
15142
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluate efficacy and safety of extended release (ER) Naproxen Sodium
Trial purpose
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
Key Participants Requirements
Sex
BothAge
15 - N/ATrial summary
Enrollment Goal
300Trial Dates
June 2011 - September 2011Phase
Phase 3Could I Receive a placebo
YesProducts
Aleve (Naproxen Sodium ER, BAY117031)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pharmaceutical Product Development, LLC | Austin, 78744, United States |
Primary Outcome
- Summed, Time-weighted Pain Intensity Difference from 0 to 24 hours postdose (SPID0-24)date_rangeTime Frame:From 0 to 24 hours post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Summed, time-weighted pain intensity differences (SPID)date_rangeTime Frame:0-6, 0-8, 0-12, 0-16 and 16-24 hours postdoseenhanced_encryptionNoSafety Issue:
- Summed, time-weighted total pain relief scores (TOTPARs)date_rangeTime Frame:0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdoseenhanced_encryptionNoSafety Issue:
- Pain Intensity Differences (PIDs) by time from initial dosedate_rangeTime Frame:At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdoseenhanced_encryptionNoSafety Issue:
- Pain Relief from initial dosedate_rangeTime Frame:At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdoseenhanced_encryptionNoSafety Issue:
- Time to first intake of rescue medicationdate_rangeTime Frame:Up to 24 hours postdoseenhanced_encryptionNoSafety Issue:
- Cumulative percentage of participants who took rescue medicationdate_rangeTime Frame:At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdoseenhanced_encryptionNoSafety Issue:
- Number of times the participants took rescue medication over the 24-hour perioddate_rangeTime Frame:24 hours postdoseenhanced_encryptionNoSafety Issue:
- Global assessment of the investigational product as a pain relieverdate_rangeTime Frame:24 hours postdose or immediately before the first intake of rescue medicationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3Additional Information
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