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

PHASE3CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 4, 2018

Primary Completion Date

July 4, 2018

Study Completion Date

December 21, 2018

Conditions
Acute Pain
Interventions
DRUG

OKITASK®

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.

OTHER

Placebo

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.

Trial Locations (3)

119146

"LLC Centre for Interdisciplinary Dentistry and Neurology", Moscow

127473

"Federal State Educational Institution Moscow State Medical Dental University named after Yevdokimov of the Russian Federation Ministry of Health", Moscow

Unknown

"State Autonomous Healthcare Institution of Yaroslavl Region Clinical Hospital of Emergency care n.a. N.V. Solovyev", Yaroslavl

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT03836807 - A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo | Biotech Hunter | Biotech Hunter