Title
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients
Phase
Phase 3Lead Sponsor
Acura Pharmaceuticals Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
PainStudy Participants
405The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.
Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.
2 tablets every 6 hours for 48 hours
2 tablets every 6 hours for 48 hours
2 tablets every 6 hours for 48 hours
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
| Event Type | Organ System | Event Term | Placebo | Acurox 5/30 | Acurox 7.5/30 |
|---|
Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5*.5 + PID1*.5 + PID2*1 + PID3*1 + PID4*1 + PID6*2 +PID12*6 + PID18*6 +PID24*6 + PID30*6 + PID36*6 + PID42*6 + PID48*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).
