Trial Condition(s):
Dental Care, Pain
Naproxen, ibuprofen and placebo in the treatment of pain secondary to dental impaction surgery
Bayer Identifier:
Trial_CC-01550
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This single center, single-dose randomized, double-blind, parallel,
placebo- and active- controlled study was designed for 175 evaluable
subjects. Subjects were randomly assigned to one of the 3 treatment
groups in the ratio of 2:2:1 (naproxen 187.5 mg [NAP187.5] or
ibuprofen 200 mg [IBU200] or placebo). Pain response was evaluated
immediately prior to administration of study drug, 1 hour and hourly
thereafter up to 12 hours. Pain intensity and pain relief were
measured on categorical scales and subjects were asked if their pain
was at least half gone from baseline at each time point. Subjects
remained in the study for up to 12 hours. Back up analgesic
medications was available for those subjects who experienced
insufficient pain relief from the study medication.
Inclusion Criteria
: - Healthy subjects > 15 years of age who experienced at least moderate pain following the surgical extraction of one or two third molars (at least one must be a mandibular partial bony or complete bony impaction).
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status |
|---|
Trial Design
Single-dose efficacy comparison of naproxen, ibuprofen and placebo in the treatment of pain secondary to dental impaction surgery
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Computing the total pain relief (TOTPAR) scores for each subjectTimeframe: at 6, 8, 10 and 12 hours
Secondary Outcome
- Summed pain intensity difference (SPID) scoresBased on a categorical scaleTimeframe: at 6, 8, 10 and 12 hours
- The proportion of time points when the subject reported starting pain at least one-half goneTimeframe:
- Peak PID: maximum pain intensity difference (PID) scoreTimeframe:
- Peak relief: maximum pain relief scoreTimeframe:
- The time to onset of pain reliefTime interval between taking study medication and onset of at least "some" pain relief (as indicated by a score of at least 2 on a 5-point scale)Timeframe:
- The proportion of subjects taking backup medicationTimeframe:
- The time interval between taking study medication and taking backup medicationTimeframe:
Additional Information
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