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

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Nausea

Vomiting

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

NorcoCommercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

PlaceboCL-108 formulation without API

Study Status

Completed

Start Date: January 2013

Completed Date: December 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.

Secondary Outcome: Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Charleston Laboratories, Inc

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01780428

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