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

This study has been completed.
Sponsor:
Information provided by:
Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00654069
First received: April 2, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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
Active Comparator: A
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
Other Name: Acurox
Active Comparator: B
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
Other Name: Acurox
Placebo Comparator: C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Acura Pharmaceuticals Inc.

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

Keywords provided by Acura Pharmaceuticals Inc.:
Pain

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Niacinamide
Oxycodone
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 29, 2014