Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy - Tabular View

Tracking Information
First Received Date ^ICMJE	April 2, 2008
Last Updated Date	April 2, 2008
Start Date ^ICMJE	September 2007
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 2, 2008)	Reduction in pain intensity [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Official Title ^ICMJE	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
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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition ^ICMJE	Pain
Intervention ^ICMJE	Drug: Oxycodone HCl/Niacin Tablets 5/30 mg Drug: Oxycodone HCl/Niacin 7.5/30 mg Drug: Placebo
Study Arms / Comparison Groups	Active Comparator: Patients will be randomized after surgery to receive 1 of 3 study treatments. Oxycodone HCl/Niacin Tablets 5/30 mg will be administered postoperatively as 2 tablets every 6 hours for 48 hours. Active Comparator: Patients will be randomized after surgery to receive 1 of 3 study treatments. Oxycodone HCl/Niacin Tablets 7.5/30 mg will be administered postoperatively as 2 tablets every 6 hours for 48 hours. Placebo Comparator: Patients will be randomized after surgery to receive 1 of 3 study treatments. Placebo will be administered postoperatively as 2 tablets every 6 hours for 48 hours
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	405
Completion Date	March 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00654069
Responsible Party	Ron J. Spivey, PhD/Sr. V.P. & Chief Scientific Officer, Acura Pharmaceuticals, Inc.
Study ID Numbers ^ICMJE	AP-ADF-105
Study Sponsor ^ICMJE	Acura Pharmaceuticals Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Acura Pharmaceuticals Inc.
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP