Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNS020QD · 1 trial · 1 indication
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
| Arm | Type | Description |
|---|---|---|
| JNS020QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| JNS020QD | DRUG | During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks. |
Inclusion Criteria: * Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent * Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent...
JNS020QD is an investigational small molecule being developed for chronic pain. It is a Phase 3 drug candidate studied in patients with chronic pain. The drug is not approved and remains in clinical development.
JNS020QD is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 3 clinical development for chronic pain.
JNS020QD is in Phase 3 clinical development for chronic pain. It is an investigational drug, meaning it is not yet approved by regulatory authorities. One Phase 3 trial has been completed.
JNS020QD has one completed Phase 3 clinical trial, identified as NCT01493245, titled "A Study of JNS020QD in Patients With Chronic Pain." The trial enrolled 77 participants in Japan and was not randomized, double-blind, or controlled.
JNS020QD is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for chronic pain. The completed trial, NCT01493245, was conducted in Japan, and no approval status has been established.