Conditions: Pain, Postoperative Tooth Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 562
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).

Detailed description:

Arms:
arm 1: Study Stage 1: One Caffeine 100 mg tablet after dental surgery; Arm Type: Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one ibuprofen 400 mg tablet, while awake, over 5 days; Arm Type: Active Comparator arm 2: Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine tablet, while awake, over 5 days; Arm Type: Experimental arm 3: Study Stage 1: One Ibuprofen 400 mg/Caffeine 100 mg tablet after dental surgery: Arm Type Experimental - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type Experimental arm 4: Study Stage 1: One Ibuprofen 400 mg tablet after dental surgery; Arm Type Active Comparator - Study Stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake, over 5 days; Arm type; Active Comparator arm 5: Study Stage 1: One Caffeine 100 mg tablet after dental surgery. Arm Type; Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type: Experimental arm 6: Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake over 5 days; Arm Type: Active Comparator

Interventions: intervention 1: ibuprofen + caffeine intervention 2: ibuprofen intervention 3: ibuprofen intervention 4: caffeine intervention 5: ibuprofen + caffeine intervention 6: placebo intervention 7: placebo intervention 8: caffeine intervention 9: ibuprofen intervention 10: ibuprofen + caffeine
Intervention descriptions: intervention 1: FDC tablet intervention 2: tablet. intervention 3: tablet intervention 4: tablet intervention 5: Fixed Dose Combination (FDC) tablet intervention 6: tablet intervention 7: tablet intervention 8: tablet intervention 9: tablet intervention 10: FDC tablet

Protocol document: