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

Charleston Laboratories, Inc460 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

460

Conditions

Pain Nausea Vomiting

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.

After data has been locked.

Time frame: Over the first 24 hours

To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.

After data has been locked.

Time frame: over 24 hours (SPID24)

Secondary Outcomes

Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.

After data lock.

Time frame: over 6 hours

Reduction of vomiting in patients treated with an opioid-containing pain reliever.