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Also known as R331333 (referred to as JNS024 ER or CG5503)
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 developed by Johnson & Johnson for the treatment of pain. It is also referred to as JNS024 ER or CG5503. The compound has been studied in a Phase 3 clinical trial in patients with chronic malignant tumor-related cancer pain.
R331333 is being developed for the treatment of pain, specifically chronic malignant tumor-related cancer pain. Its Phase 3 trial enrolled Japanese and Korean patients with cancer pain. The drug is an extended-release formulation studied under the name JNS024 ER.
R331333 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 3 clinical trial of the drug in patients with chronic malignant tumor-related cancer pain.
R331333 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication based on the available development information.
R331333 has been studied in one Phase 3 trial, NCT01165281, titled a safety and efficacy study of JNS024 Extended Release in Japanese and Korean patients with chronic malignant tumor-related cancer pain. The completed trial enrolled 343 patients, was randomized, double-blind, and active-controlled, and was conducted in Japan and South Korea.
Yes, R331333 is also known as JNS024 ER and CG5503. These names refer to the same investigational small molecule developed by Johnson & Johnson for pain. The Phase 3 trial of the drug was conducted under the JNS024 Extended Release designation.