drugset / Trial / NCT00993798
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.
Timeline
- Start
- 2009-04
- Primary completion
- 2011-06
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 20 ml | — |
| Subject | SABER-Bupivacaine | Unknown | 5 ml | — |
| Subject | SABER-Bupivacaine | Unknown | 7.5 ml | — |
Indications
No indication recorded.