At a glance
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A Multicenter, Double Blind, Randomised, Parallel Study to Assess Efficacy and Tolerability After Single Administration of Ketoprofen Lysine Salt 40 mg Granules vs Placebo in Subjects With Acute Pain Syndrome After Removal of Molar Teeth
In Brief
A Phase 3 clinical trial evaluating OKITASK® and Placebo for Acute Pain. Completed, enrolled 70 participants across 3 sites.
Detailed 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)
Study Details
Timeline
Interventions
A single oral dose of OKITASK® 40 mg was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen). The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.
A single oral dose of matching Placebo was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained Placebo. The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.