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

Sponsor:	Acura Pharmaceuticals Inc.
Information provided by:	Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00654069

Purpose

The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

Condition	Intervention	Phase
Pain	Drug: Oxycodone HCl/Niacin Tablets 5/30 mg Drug: Oxycodone HCl/Niacin 7.5/30 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Niacin Oxycodone Niacinamide Oxycodone hydrochloride Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Acura Pharmaceuticals Inc.:

Primary Outcome Measures:

Reduction in pain intensity [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment:	405
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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.	Drug: Oxycodone HCl/Niacin Tablets 5/30 mg Tablets 5/30 mg, 2 tablets every 6 hours for 48 hours
B: 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.	Drug: Oxycodone HCl/Niacin 7.5/30 mg Tablets 7.5/30 mg, 2 tablets every 6 hours for 48 hours
C: 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	Drug: Placebo Tablets, 2 tablets every 6 hours for 48 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Acura Pharmaceuticals, Inc. ( Ron J. Spivey, PhD/Sr. V.P. & Chief Scientific Officer )
Study ID Numbers:	AP-ADF-105
Study First Received:	April 2, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00654069 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acura Pharmaceuticals Inc.:

Pain

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Niacinamide
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Oxycodone
Central Nervous System Depressants
Narcotics
Cardiovascular Agents

Pharmacologic Actions
Nicotinic Acids
Sensory System Agents
Therapeutic Uses
Vitamins
Peripheral Nervous System Agents
Analgesics
Micronutrients
Central Nervous System Agents
Niacin
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 09, 2009