OCT to conduct a phase III trial in patients with acute dental pain

This is an open-label, multicentre, randomized, parallel group study in patients with moderate to severe pain after removal of at least two third molars.

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 18 to 60 will be screened. Randomized subjects will be allocated into two equal therapeutic groups depending on the type of anesthesia 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 last 48 hours.

There are many analgesic options available to physicians today, but most of them have limitations and may not provide sufficient pain relief. A simple combination treatment could have the advantage of increasing analgetic action without having to raise the dose of such drugs, thereby contribute to a better safety profile. 

Except for biostatistics, OCT team is responsible for all aspects of conducting this study, including review of sponsor’s Clinical Study Protocol and Investigator’s Brochure, as well as for all subsequent registration steps.