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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00487435 | An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain | PHASE3 | COMPLETED | 1,166 | — | — | Jun 1, 2007 | Jun 1, 2009 | May 9, 2014 | 148 | United States, Australia +2 |
The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Tapentadol (CG5503) Extended Release (ER) 100 150 200 250 mg oral tablet twice daily for 52 weeks |
| Name | Type | Description |
|---|---|---|
| Tapentadol (CG5503) Extended Release (ER) | DRUG | 100, 150, 200, 250 mg oral tablet twice daily for 52 weeks |
Inclusion Criteria: * Non-lactating female subjects (Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control \[e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive pat...