Overview
An International Trial to Evaluate the Efficacy and Safety of SABERĀ®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Status:
Completed
Completed
Trial end date:
2010-07-01
2010-07-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy 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 the efficacy and safety of the product.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
DurectCollaborators:
Nycomed
TakedaTreatments:
Bupivacaine
Criteria
Inclusion Criteria:- A planned elective, abdominal hysterectomy
- Patients suitable for general anaesthesia
Exclusion Criteria:
- Known clinically significant hepatic, gastrointestinal, renal, haematological,
urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances.
History of cured localised malignancies is allowed (i.e. basal or squamous cell skin
carcinoma, breast carcinoma or cervical carcinoma)
- Abnormal ECG
- Prolonged QT syndrome
- Current or regular use of analgesic medication for other indication(s)