Evidence map›Paper›PMID 29564045›Full record

Trial reportClinics in orthopedic surgery2018

Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders.

Chang Ju Hwang, Sung Soo Chung, Kyu-Yeol Lee, Jae Hyup Lee, Seong-Hwan Moon, Jin-Hyok Kim, Kyu-Jung Cho, Jae-Sung Ahn, Dong-Soo Kim, Ye-Soo Park and 1 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Clinics in orthopedic surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01811238 (A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01811238 phase4completednot on this map

A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN(R) (Oxycodone/Naloxone) in Korean Patients With Spinal Disorders

TypeinterventionalSponsorMundipharma Korea LtdRan2012 to 2013Enrolled240ConditionsSpinal DisordersArmsOxycodone/naloxone
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 1 country.

Chang Ju HwangDepartment of Orthopaedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Sung Soo ChungDepartment of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kyu-Yeol LeeDepartment of Orthopaedic Surgery, Dong-A University Hospital, Busan, Korea.
Jae Hyup LeeDepartment of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
Seong-Hwan MoonDepartment of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Jin-Hyok KimDepartment of Orthopedic Surgery, Seoul Spine Institute, Inje University Sanggye Paik Hospital, Seoul, Korea.
Kyu-Jung ChoDepartment of Orthopaedic Surgery, Inha University Hospital, Incheon, Korea.
Jae-Sung AhnDepartment of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.
Dong-Soo KimDepartment of Orthopaedic Surgery, Chungbuk National University Hospital, Cheongju, Korea.
Ye-Soo ParkDepartment of Orthopaedic Surgery, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
Hye-Jeong ParkMundipharma Korea Ltd., Seoul, Korea.
Asan Medical Center · KRChungbuk National University Hospital · KRChungnam National University Hospital · KRDong-A University Hospital · KRHanyang University Guri Hospital · KRInha University Hospital · KRSamsung Medical Center · KRSeoul National University · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain.

methodsIn this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0-10) and the Korean-language EuroQol-five dimensions questionnaire, respectively.

resultsAmong 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (

conclusionsProlonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238).

Indexed as

AgedAnalgesics, OpioidBack PainChronic PainConstipationDelayed-Action PreparationsDizzinessDrug CombinationsFemaleHumansIntention to Treat AnalysisMaleMiddle AgedNaloxoneNauseaOxycodoneAnalgesics, OpioidDelayed-Action PreparationsDrug CombinationsNaloxoneOxycodoneoxycodone naloxone combinationAnalgesiaChronic painOxycodone naloxone combinationSpine

Identifiers

PMID29564045
PMCPMC5851852
OpenAlexW2780038620

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.