Phase 3
Completed N=405
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Source: ClinicalTrials.gov NCT00654069 ↗Enrolled (actual)
405
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: SPID48 — 604.48; 998.46; 1224.97 score on a scale
◆ Published Evidence
Established
23citations · ~2 / year
Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
Summary
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
Linked Publications
-
Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SPID48 |
604.48; 998.46; 1224.97 | — |
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
Data sourced from ClinicalTrials.gov (NCT00654069) and the linked publication. 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. Informational only — not medical advice.