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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT00993226
First received: October 9, 2009
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: SABER-Bupivacaine Treatment 1a
Drug: Placebo SABER-Bupivacaine Treatment 1b
Drug: Bupivacaine HCl Treatment 1c
Drug: SABER-Bupivacaine Treatment 2a
Drug: Placebo SABER-Bupivacaine Treatment 2b
Drug: Bupivacaine HCl Treatment 2c
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Undergoing Primary, Elective, Open, Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Pain intensity (PI) [ Time Frame: 0-3 days after surgery ] [ Designated as safety issue: No ]
  • Supplemental opioid use [ Time Frame: 0-3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
  • Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SABER-Bupivacaine Treatment 1a
double-blind
Drug: SABER-Bupivacaine Treatment 1a
5.0 ml
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 1b
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
Active Comparator: Bupivacaine HCl Treatment 1c
double-blind
Drug: Bupivacaine HCl Treatment 1c
40 ml
Experimental: SABER-Bupivacaine Treatment 2a
double-blind
Drug: SABER-Bupivacaine Treatment 2a
7.5 ml
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 2b
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
Active Comparator: Bupivacaine HCl Treatment 2c
double-blind
Drug: Bupivacaine HCl Treatment 2c
40 ml

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993226

Locations
France
Nycomed
Paris, France
Germany
Nycomed
Bayreuth, Germany
Nycomed
Dresden, Germany
Hungary
Nycomed
Budapest, Hungary
Nycomed
Békéscsaba, Hungary
Nycomed
Debrecen, Hungary
Nycomed
Györ, Hungary
Nycomed
Nyíregyháza, Hungary
Nycomed
Szolnok, Hungary
Nycomed
Székesfehérvár, Hungary
Nycomed
Tatabánya, Hungary
Latvia
Nycomed
Riga, Latvia
Sweden
Nycomed
Stockholm, Sweden
United Kingdom
Nycomed
London, United Kingdom
Sponsors and Collaborators
Durect
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT00993226     History of Changes
Other Study ID Numbers: BU-001-IM
Study First Received: October 9, 2009
Last Updated: January 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Latvia: State Agency of Medicines

Keywords provided by Durect:
Postoperative pain
Local anaesthesia
Postoperative pain after open abdominal hysterectomy surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014