Overview

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.