Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2013 |
| End Date: | November 2013 |
| Contact: | Benard P Schachtel, M.D. |
| Email: | bschachlet@charlestonlabs.com |
| Phone: | 5615757330 |
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
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
severs pain following surgical removal of impacted third molar teeth.
A positive control ( Norco, A commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) is
included to determine the anti-emetic effects of CL-108.
CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to
severs pain following surgical removal of impacted third molar teeth.
A positive control ( Norco, A commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) is
included to determine the anti-emetic effects of CL-108.
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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