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

Charleston Laboratories

Status and phase: Completed; Phase 3

Conditions: Vomiting; Nausea; Pain

Treatments: Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01780428

CLCT-002

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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460 participants in 3 patient groups, including a placebo group

CL-108

Experimental group

Description:

CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)

Treatment:

Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

Norco

Active Comparator group

Description:

Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

Treatment:

Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

Placebo

Placebo Comparator group

Description:

CL-108 formulation without API

Treatment:

Drug: Placebo