stop_circleTerminated/Withdrawn
Dental Care, Pain
Bayer Identifier:
Trial_CC-00594
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Ibuprofen, and placebo in the treatment of pain secondary to dental impaction surgery
Trial purpose
This was a single-dose, randomized, parallel, double-blind design
requiring 175 evaluable subjects at a single center. Subjects were
randomly assigned to one of the 3 groups in 2:2:1 ratio to receive a
single dose of naproxen (187.5 mg), ibuprofen (200 mg), or placebo.
After dosing with study medication, the subjects had to remain at the
study site for 2 hours. Analgesic response was evaluated on
categorical scales by subjects’ ratings of their pain intensity and pain
relief. Pain intensity was evaluated immediately prior to study drug
administration, and both pain intensity and pain relief were evaluated
hourly thereafter for 12 hours following study drug administration.
requiring 175 evaluable subjects at a single center. Subjects were
randomly assigned to one of the 3 groups in 2:2:1 ratio to receive a
single dose of naproxen (187.5 mg), ibuprofen (200 mg), or placebo.
After dosing with study medication, the subjects had to remain at the
study site for 2 hours. Analgesic response was evaluated on
categorical scales by subjects’ ratings of their pain intensity and pain
relief. Pain intensity was evaluated immediately prior to study drug
administration, and both pain intensity and pain relief were evaluated
hourly thereafter for 12 hours following study drug administration.
Key Participants Requirements
Sex
AllAge
17 - 43 YearsTrial summary
Enrollment Goal
12Trial Dates
June 1992 - July 1992Phase
Phase 3Could I Receive a placebo
YesProducts
Aleve (Naproxen Sodium, BAY117031)Accepts Healthy Volunteer
N/APrimary Outcome
- Total pain relief (TOTPAR) scoresdate_rangeTime Frame:6, 8, 10, and 12 hours
Secondary Outcome
- Summed pain intensity difference (SPID) scoresBased on a categorical scaledate_rangeTime Frame:6-, 8-, 10- and 12-hour
- The proportion of time points when the subject reported starting pain at least one-half gone
- Peak PID: maximum pain intensity difference (PID) score
- 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