A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

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

Sponsors

Lead sponsor: Charleston Laboratories, Inc

Source 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.

Overall Status Completed
Start Date January 2013
Completion Date December 2014
Primary Completion Date October 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco. 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. over 24 hours (SPID24)
Secondary Outcome
Measure Time Frame
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever. over 6 hours
Reduction of vomiting in patients treated with an opioid-containing pain reliever. over 6 hours
Enrollment 460
Condition
Intervention

Intervention type: Drug

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

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility University of Pennsylvania
Location Countries

United States

Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: CL-108

Arm group type: Experimental

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

Arm group label: Norco

Arm group type: Active Comparator

Description: Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: CL-108 formulation without API

Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov