A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Status:
Completed
Trial end date:
2018-12-21
Target enrollment:
Participant gender:
Summary
Primary objective:
To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain
syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile
measured by VAS.
Secondary objectives:
To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus
Placebo in patients with acute pain syndrome after removal of one molar tooth:
- Time profile of pain and time profile of pain relief using VAS scales
- Time to first perceptible pain relief (TFPR) and time to meaningful pain relief (TMPR)
- Proportion of patients requiring rescue medication (analgesia) and time to rescue
analgesia
- Patient's overall assessment
- Rate of adverse events (AE)