Status:
COMPLETED
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Lead Sponsor:
Durect
Collaborating Sponsors:
Nycomed
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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....
Eligibility Criteria
Inclusion
- A planned elective, abdominal hysterectomy
- Patients suitable for general anaesthesia
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00993226
Start Date
May 1 2009
End Date
July 1 2010
Last Update
June 1 2021
Active Locations (14)
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1
Nycomed
Paris, France
2
Nycomed
Bayreuth, Germany
3
Nycomed
Dresden, Germany
4
Nycomed
Békéscsaba, Hungary