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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charleston Laboratories, Inc
• Treatments: Acetaminophen; Diphenhydramine; Hydrocodone; Promethazine

Criteria

Inclusion Criteria:

• Determination of being likely or possibly nausea-prone.

• Male or non-pregnant and non-lactating female.

• Surgical extraction of at least 2 impacted third molar teeth

• A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control.

• Surgical extraction of at least 2 impacted third molar teeth.

• Presence of at least moderate post-operative pain.

Exclusion Criteria:

• Medial Condition, presence of a serious medical condition.

• Active local infection.

• Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.

• Caffeine use since midnight before the operation.

• Use of an IND Drug within past 30 days.

• Previous participation in this study.

• Pregnant or lactating.

• Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.