Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

Summary

This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth. A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.

Timeline

Start

2013-01

Primary completion

2013-10

Completion

2014-12

Drugs

Indications

No indication recorded.