The study hypothesis is that the analgesic effects of the investigational drug (pain relief after dental surgery) will be greater than that of the study comparator.
Up to 130 patients are expected to participate in the study. For this purpose, up to 170 men and women aged from 18 to 60 will be screened. Randomized subjects will be allocated into two equal therapeutic groups depending on the type of anaesthesia used for the surgery. The enrolment will include patients with moderate to severe post-surgical pain after dental surgery for the removal of two impacted third molar teeth. The duration of treatment will be 48 hours.
There are many analgesic options available to physicians today, but most of them have limitations and may not provide sufficient analgesia. A simple combination treatment could have the advantage of increasing analgesia without having to raise the dose of such drugs, thereby taking advantage of the better safety profile.
Except for biostatistics, OCT team is responsible for all aspects of conducting this study, including review of the sponsor’s Clinical Study Protocol and Investigator’s Brochure, as well as for all subsequent registration steps.