An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
NCT ID: NCT00993226
Last Updated: 2021-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2009-05-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SABER-Bupivacaine Treatment 1a
double-blind
SABER-Bupivacaine Treatment 1a
5.0 ml
Placebo SABER-Bupivacaine Treatment 1b
double-blind
Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
Bupivacaine HCl Treatment 1c
double-blind
Bupivacaine HCl Treatment 1c
40 ml
SABER-Bupivacaine Treatment 2a
double-blind
SABER-Bupivacaine Treatment 2a
7.5 ml
Placebo SABER-Bupivacaine Treatment 2b
double-blind
Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
Bupivacaine HCl Treatment 2c
double-blind
Bupivacaine HCl Treatment 2c
40 ml
Interventions
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SABER-Bupivacaine Treatment 1a
5.0 ml
Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
Bupivacaine HCl Treatment 1c
40 ml
SABER-Bupivacaine Treatment 2a
7.5 ml
Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
Bupivacaine HCl Treatment 2c
40 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients suitable for general anaesthesia
Exclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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Nycomed
INDUSTRY
Durect
INDUSTRY
Responsible Party
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Principal Investigators
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Nycomed Clinical Trial Operations
Role: STUDY_CHAIR
Headquarters
Locations
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Nycomed
Paris, , France
Nycomed
Bayreuth, , Germany
Nycomed
Dresden, , Germany
Nycomed
Békéscsaba, , Hungary
Nycomed
Budapest, , Hungary
Nycomed
Debrecen, , Hungary
Nycomed
Győr, , Hungary
Nycomed
Nyíregyháza, , Hungary
Nycomed
Székesfehérvár, , Hungary
Nycomed
Szolnok, , Hungary
Nycomed
Tatabánya, , Hungary
Nycomed
Riga, , Latvia
Nycomed
Stockholm, , Sweden
Nycomed
London, , United Kingdom
Countries
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Other Identifiers
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BU-001-IM
Identifier Type: -
Identifier Source: org_study_id
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