At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
Oxycodone CR +1 moredrug
Likely dose
Oxycodone CR 5 mgfrom 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.
A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain
In Brief
A Phase 3 clinical trial evaluating Oxycodone CR and R331333 (referred to as JNS024 ER or CG5503) for Pain. Completed, enrolled 343 participants across 52 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesJapan, South Korea
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartAug 2010
Primary CompletionAug 2012
TodayJul 2026
First PostedJul 19, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.0 years ago
Interventions
Oxycodone CRdrug
One 5 mg to 40 mg capsule twice daily for 4 weeks.
R331333 (referred to as JNS024 ER or CG5503)drug
One 25 mg to 200 mg capsule twice daily for 4 weeks.