ClinicalTrials.gov

History of Changes for Study: NCT00654069
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Latest version (submitted August 21, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 2, 2008 None (earliest Version on record)
2 August 21, 2018 Arms and Interventions, Study Status, Sponsor/Collaborators, Outcome Measures, Results, Study Description and Study Identification
Comparison Format:

Scroll up to access the controls

Study NCT00654069
Submitted Date:  April 2, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: AP-ADF-105
Brief Title: Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2008
Overall Status: Completed
Study Start: September 2007
Primary Completion: February 2008 [Actual]
Study Completion: March 2008 [Actual]
First Submitted: April 2, 2008
First Submitted that
Met QC Criteria:
April 2, 2008
First Posted: April 7, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 2, 2008
Last Update Posted: April 7, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Acura Pharmaceuticals Inc.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pain
Keywords: Pain
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 405 [Actual]
Open or close this module Arms and Interventions
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 Names:
  • 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 Names:
  • 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Reduction in pain intensity
[ Time Frame: 48 hours ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services