A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery

Pain Clinical Trial

Official title:
A Multi-center, Randomized, Multiple-dose, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Abuse-deterrent Capsules Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (b) for the Treatment of Adults With Moderate to Severe Pain Following Bunionectomy Surgery

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation.

Clinical Trial Description

The study is designed to evaluate the safety and efficacy of oxycodone/naltrexone (a) and oxycodone/naltrexone (b) versus placebo. During the blinded phase of the study (inpatient portion) the dosing regimen is 1 capsule containing Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone plus Naltrexone Hydrochloride (b) or placebo taken with 4 to 6 ounces (oz) of water every 6 hours (q6h) for 48 hours following the first dose (Multiple-dose Period) while in-house. Then for the open-label phase of the study (outpatient portion) dosing will occur every 4 to 6 hours prn with Oxycodone plus naltrexone. The active and placebo study medications will appear identical. Study subjects with acute postoperative pain of moderate to severe intensity following unilateral bunionectomy surgery will be randomized after surgery, and will stay at the study center for the duration of the 48-hour double-blind period after dose 1 of study medication. The study will be conducted in the following 4 periods: 1) a pre-treatment period, 2) a multiple-dose inpatient period (double-blind), 3) a multiple-dose outpatient period (open-label), and 4) End of Study/Follow-up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Pain

Clinical Trial Details

NCT number	NCT02401750
Study type	Interventional
Source	Elite Laboratories, Inc
Contact
Status	Completed
Phase	Phase 3
Start date	June 2015
Completion date	September 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.