Trial | NCT01780428  Report issue

Title

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

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    460
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 Started
Jan 31
2013
Primary Completion
Oct 31
2013
Study Completion
Dec 31
2014
Last Update
Nov 03
2016
Estimate

Drug CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) [hydrocodone (hycodan), acetaminophen (tylenol), promethazine hydrochloride (phenergan)]

  • Other names: Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo

Drug Placebo

CL-108 Experimental

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

Norco Active Comparator

Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

Placebo Placebo Comparator

CL-108 formulation without API

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.
No Results Posted