Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.