An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

Summary

Study Objectives: 1. Primary objective \- To assess the pain reduction after 8 weeks treatment from baseline (week 0) 2. Secondary objectives * To assess the pain reduction after 4 weeks treatment from baseline (week 0) * To assess the EQ-5D * To assess physician's overall satisfaction * To assess subject's overall satisfaction * To assess safety

Timeline

Start

2012-09

Primary completion

2013-04

Completion

2013-07

Outcome

Met primary endpoint

registry Oxycodone/Naloxone; p <0.05; Mean Difference (Final Values) -1.69; t-test, 2 sided NCT01811238 ↗

paper the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). PMID 29564045 ↗

Publications

• Hwang CJ, Chung SS, Lee KY, Lee JH, Moon SH, Kim JH, Cho KJ, Ahn JS, Kim DS, Park YS, Park HJ. Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders. Clin Orthop Surg. 2018 Mar;10(1):33-40. doi: 10.4055/cios.2018.10.1.33. Epub 2018 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxycodone/naloxone	Unknown	5 mg	Oral
Subject	Oxycodone/naloxone	Unknown	10 mg	Oral
Subject	Oxycodone/naloxone	Unknown	20 mg	Oral
Subject	Oxycodone/naloxone	Unknown	40 mg	Oral

Indications