Philadelphia, Pennsylvania 19104

  • Vomiting


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.


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.



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Philadelphia, Pennsylvania 19104
United States

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Site Status: N/A

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Date Processed: June 20, 2021

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