CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
Oxycodone/Naloxone +1 moredrug
Likely dose
Oxycodone/Naloxone 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01313780
NCT01313780Phase 4Completed
CompareCT.gov

A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP)

Mundipharma Korea Ltd·interventional·Posted Mar 14, 2011·Updated Dec 22, 2017

In Brief

A Phase 4 clinical trial evaluating Oxycodone/Naloxone and Oxycodone(single compound) for Cancer. Completed, enrolled 128 participants across 1 site.

Detailed Summary

Objectives: To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity 1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks 2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.3 years ago

Interventions

Oxycodone/Naloxonedrug

Dose and administration : Upto 40mg B.I.D per daily.

Oxycodone(single compound)drug

Dose and administration : Upto 40mg B.I.D per daily.