Status:
COMPLETED
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Lead Sponsor:
Acura Pharmaceuticals Inc.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
Detailed Description
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of mo...
Eligibility Criteria
Inclusion
- Patient is male or female at least 18 years of age
- For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- Patient is scheduled to have a bunionectomy
- Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery
Exclusion
- Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- Patient has used or intends to use any of the medications that are prohibited by the protocol
- Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
- Patient is hypersensitive to any of the medications to be used in the study
- Patient has taken another investigational drug within 30 days prior to Screening
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00654069
Start Date
September 1 2007
End Date
March 1 2008
Last Update
August 22 2018
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