Phase 3 N=405 Randomized Double-blind Treatment

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00654069 ↗

Enrolled (actual)

405

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: SPID48 — 604.48; 998.46; 1224.97 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Acurox 5/30 mg (Drug); Acurox 7.5/30 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Acura Pharmaceuticals Inc.
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY SPID48	604.48; 998.46; 1224.97	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00654069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.