Overview

An International Trial to Evaluate the Efficacy and Safety of SABERĀ®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Durect
Collaborators:
Nycomed
Takeda
Treatments:
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)