Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01165281 | A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain | PHASE3 | COMPLETED | 343 | — | — | Aug 1, 2010 | Aug 1, 2012 | Jul 21, 2017 | 52 | Japan, South Korea |
The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: "What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine." The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | R331333 (referred to as JNS024 ER or CG5503) One 25 mg to 200 mg capsule twice daily for 4 weeks. |
| 002 | ACTIVE_COMPARATOR | Oxycodone CR One 5 mg to 40 mg capsule twice daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Oxycodone CR | DRUG | 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. |
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 rec...