Trials / Withdrawn
WithdrawnNCT01303107
Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean
A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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).
Detailed description
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bupivacaine | single dose of 15 mg by a slow injection rate of 1 mL/s |
Timeline
- First posted
- 2011-02-24
- Last updated
- 2014-03-26
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01303107. Inclusion in this directory is not an endorsement.