Clinical trial NCT01780428: Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Nausea
Vomiting
Keywords: Pain
Nausea
Vomiting
Lead sponsor: Charleston Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-31
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
timeFrame: Over the first 24 hours
measure: To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
timeFrame: over 24 hours (SPID24)
Secondary outcomes:
measure: Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
timeFrame: over 6 hours
measure: Reduction of vomiting in patients treated with an opioid-containing pain reliever.
timeFrame: over 6 hours
Other outcomes:
measure: Elimination of vomiting in patients treated with an opioid-containing pain reliever.
timeFrame: 6 hours and 24 hours
measure: Elimination of nausea in patients treated with an opioid-containing pain reliever.
timeFrame: 6 hours and 24 hours
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: