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:
Durect
Collaborator:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT00993226
First received: October 9, 2009
Last updated: January 30, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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
Nycomed: A Takeda Company
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 May 21, 2013