drugset / Trial / NCT01709214
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
Timeline
- Start
- 2012-12-04
- Primary completion
- 2014-04
- Completion
- 2014-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cebranopadol | Small molecule | 200 ug | Oral |
| Subject | Cebranopadol | Small molecule | 300 ug | Oral |
| Subject | Cebranopadol | Small molecule | 400 ug | Oral |
| Subject | Cebranopadol | Small molecule | 600 ug | Oral |
| Subject | Cebranopadol | Small molecule | 800 ug | Oral |
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 20 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 30 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 40 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 50 mg | Oral |
Indications
No indication recorded.