Title
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin Test Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Phase
Phase 2Lead Sponsor
IrokoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dental PainIntervention/Treatment
indomethacin celecoxib ...Study Participants
203The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
Capsules 2 x 200 mg Single-Dose
Capsules 2 Single-Dose
20-mg single dose
40-mg single dose
Inclusion Criteria: Patient is male or female between 18 and 50 years of age For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control Patient requires extraction of 2 or more third molars Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug Exclusion Criteria: Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs Patient has a current disease or history of a disease that will impact the study or the patient's well-being Patient has used or intends to use any of the medications that are prohibited by the protocol Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test Patient has taken another investigational drug within 30 days prior to Screening
| Event Type | Organ System | Event Term | Indomethacin Test (Lower Dose) | Indomethacin Test (Upper Dose) | Celecoxib 400 mg | Placebo |
|---|
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32.
