NCT01780428

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

A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Charleston Laboratories, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
DRUG	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-10-01
• Completion: 2014-12-01
• First posted: 2013-01-31
• Last updated: 2016-11-03

Locations

1 site across 1 country: United States