Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol PR · 1 trial · 2 indications
Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.
| Arm | Type | Description |
|---|---|---|
| Opioid-Naive Participants (Tapentadol PR) | EXPERIMENTAL | Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| Opioid-Switch Participants (Tapentadol PR) | EXPERIMENTAL | Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
| Name | Type | Description |
|---|---|---|
| Tapentadol PR | DRUG | Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days. |
Inclusion Criteria: * Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations \[120 milligram per day {mg/day} or less\], oxycodone hydrochloride sustained releas...
Tapentadol PR is an investigational small molecule being studied for the treatment of pain in cancer patients. It is a prolonged release formulation of tapentadol, designed to provide extended pain relief. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Tapentadol PR is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for cancer-related pain.
Tapentadol PR is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials. The drug is being evaluated for its potential to treat pain in cancer patients.
Tapentadol PR has one completed Phase 2 clinical trial with the identifier NCT00805142. This trial, titled 'Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants,' was conducted in Japan and enrolled 78 participants aged 20 years and older. The study evaluated the drug's effects on cancer-related pain.
Tapentadol PR is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The drug is being studied for the treatment of pain in cancer patients, but it has not yet completed the clinical trials and regulatory review process required for approval.