Clinical trial · Interventional
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone CR | Drug | — | UNRESOLVED |
| R331333 (referred to as JNS024 ER or CG5503) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- description
- R331333 (referred to as JNS024 ER or CG5503) One 25 mg to 200 mg capsule twice daily for 4 weeks.
- interventionNames
- Drug: R331333 (referred to as JNS024 ER or CG5503)
- type
- ACTIVE_COMPARATOR
- label
- 002
- description
- Oxycodone CR One 5 mg to 40 mg capsule twice daily for 4 weeks.
- interventionNames
- Drug: Oxycodone CR
Primary outcomes (1)
- measure
- Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Documented clinical diagnosis of any type of cancer * Diagnosis of chronic malignant tumor-related cancer pain with an average score for pain intensity in the past 24 hours of \>=4 on the 11-point numerical rating scale (NRS) on the day of randomization (Day -1) * Have not received treatment with opioid analgesics within 28 days before screening (Note: codeine phosphate \[\<=60 mg/d\] or dihydrocodeine phosphate \[\<=30 mg/d\] for antitussive use are allowed) * Dissatisfied with pain relief by the current treatment and for whom the investigator or designee judges that treatment with opioid analgesics is required Exclusion Criteria: * Have complicated with uncontrolled/clinically significant arrhythmia * Have previous or concurrent presence of any disease which may develop increased intracranial pressure, disturbance of consciousness, lethargy, or respiratory problems such as traumatic encephalopathy with cerebral contusion, intracranial hematoma, disturbance of consciousness, brain tumor, cerebral infarction, transient ischemic attack, epilepsy or convulsive diseases * Have history of alcohol and/or drug abuse * Have any disease for which opioids are contraindicated such as serious respiratory depression of serious chronic obstructive pulmonary disease, bronchial asthma attack, cardiac failure secondary to chronic pulmonary disease, paralytic ileus, status epileptics, tetanus, strychnine poisoning, acute alcohol poisoning, hypersensitivity to opium alkaloid, hemorrhagic colitis, or bacterial diarrhea
References
Publications (1)
- DERIVEDImanaka K, Tominaga Y, Etropolski M, van Hove I, Ohsaka M, Wanibe M, Hirose K, Matsumura T. Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Curr Med Res Opin. 2013 Oct;29(10):1399-409. doi: 10.1185/03007995.2013.831816. Epub 2013 Aug 23. PMID 23937387