Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
Completed · Phase 3 · Has a placebo group
Conditions studied: Pain, Nausea, Vomiting
In brief
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.
Key facts
- Study ID
- NCT01780428
- Run by
- Charleston Laboratories, Inc
- People needed
- 460
- Starts
- 2013-01-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2016-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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