Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Information source: Acura Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Oxycodone HCl/Niacin Tablets 5/30 mg (Drug); Oxycodone HCl/Niacin 7.5/30 mg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Acura Pharmaceuticals Inc.
Summary
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in
the treatment of pain following bunionectomy surgery.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Repeat-Dose Study of the Safety and Efficacy of OxyADF (Oxycodone HCl and Niacin) Tablets for the Treatment of Acute, Moderate to Severe Postoperative Pain Following Bunionectomy Surgery in Adult Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Reduction in pain intensity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: September 2007
Last updated: April 2, 2008
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