check_circleStudy Completed
Dental Care, Pain
Bayer Identifier:
Trial_CC-01550
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Naproxen, ibuprofen and placebo in the treatment of pain secondary to dental impaction surgery
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.
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.
Key Participants Requirements
Sex
N/AAge
15 YearsTrial summary
Enrollment Goal
175Trial Dates
June 1992 - July 1992Phase
Phase 4Could I Receive a placebo
YesProducts
Aleve (Naproxen Sodium, BAY117031)Accepts Healthy Volunteer
N/APrimary Outcome
- Computing the total pain relief (TOTPAR) scores for each subjectdate_rangeTime Frame:at 6, 8, 10 and 12 hours
Secondary Outcome
- Summed pain intensity difference (SPID) scoresBased on a categorical scaledate_rangeTime Frame:at 6, 8, 10 and 12 hours
- The proportion of time points when the subject reported starting pain at least one-half gone
- Peak PID: maximum pain intensity difference (PID) score
- Peak relief: maximum pain relief score
- 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)
- The proportion of subjects taking backup medication
- The time interval between taking study medication and taking backup medication
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3