drugset / Trial / NCT01303107
Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean
Phase 3
Withdrawn
Cristália Produtos Químicos Farmacêuticos Ltda.
Irmandade da Santa Casa da Misericórdia de Santos · collabIrmandade da Santa Casa de Misericordia de Sao Paulo · collab
RandomizedParallel-groupTriple-blindSupportive care
Summary
The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Outcome
Outcome not reported
Stopped: “The Sponsor has no interest in continuing the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 15 mg | Intrathecal |
Indications
No indication recorded.