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

Phase 3

Completed

• Conditions: Nausea; Pain; Vomiting
• Interventions: Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg); Drug: Placebo

• Registration Number: NCT01780428
• Lead Sponsor: Charleston Laboratories, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Primary Completion: 2013-10
• Study Completion: 2014-12
• Status Verified: 2016-11
• Disposition First Submitted: 2016-11-02
• Disposition First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Disposition First Posted: 2016-11-03
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Norco	CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)	Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
CL-108	CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)	CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)
Placebo	Placebo	CL-108 formulation without API

Primary Outcome Measures

Name	Time	Method
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.	Over the first 24 hours	After data has been locked.
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.	over 24 hours (SPID24)	After data has been locked.

Secondary Outcome Measures

Name	Time	Method
Reduction of vomiting in patients treated with an opioid-containing pain reliever.	over 6 hours	After data lock.
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.	over 6 hours	After data lock.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States