Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R331333 · 1 trial · 1 indication
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...
R331333 is an investigational small molecule being developed for the treatment of pain. It is being studied specifically for chronic malignant tumor-related cancer pain in Japanese and Korean patients. The drug is currently in Phase 3 clinical development.
R331333 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for pain management.
R331333 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, active-controlled study. The drug is investigational and has not been approved by regulatory authorities.
R331333 has been studied in one completed Phase 3 clinical trial, NCT01165281. This trial evaluated the safety and efficacy of JNS024 Extended Release (ER) in Japanese and Korean patients with chronic malignant tumor-related cancer pain. The trial enrolled 343 participants.
Yes, R331333 is also known as JNS024. The Phase 3 clinical trial NCT01165281 evaluated JNS024 Extended Release (ER) in patients with cancer pain, and this same drug is referred to as R331333 in development records.