A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo — KSL0117  

Acute Pain Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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)

Clinical Trial Description

This is a multicenter, double blind, randomized, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.

The patients are assigned to one of two treatment group in 1:1 ratio:

• Group 1. OKITASK® 40 mg - 35 patients;

• Group 2. Placebo - 35 patients. The study was conducted at 3 Russian sites. A total number of enrolled subjects was 70 (35 per each group). Patients' enrollment was competitive.

The study consisted of three periods: screening, study treatment and follow-up. The duration of participation of each subject in the study was to be up to 7±1 days and included: screening (up to 4 days), tooth extraction, randomization and study treatment (1 day), and follow-up (2 days). ;

Related Conditions & MeSH terms

• Acute Pain

• NCT number: NCT03836807
• Study type: Interventional
• Source: Dompé Farmaceutici S.p.A
• Status: Completed
• Phase: Phase 3
• Start date: April 4, 2018
• Completion date: December 21, 2018