drugset
drugset / Trial / NCT03836807

A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo

NCT03836807 ↗

Phase 3 Completed 70 enrolled Dompé Farmaceutici S.p.A
RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start
2018-04-04
Primary completion
2018-07-04
Completion
2018-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketoprofen Small molecule 40 mg Oral

Indications

No indication recorded.