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An International Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
This study has been completed.
Sponsor:
Durect
Collaborator:
Takeda
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT00993798
First received: October 9, 2009
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery 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 safety.
| 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 (Participant, 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 Following Arthroscopic Shoulder Surgery |
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 ]
- Supplemental opioid use [ Time Frame: 0-3 days after surgery ]
Secondary Outcome Measures:
- Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ]
- Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ]
| Enrollment: | 107 |
| Study Start Date: | April 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | June 2011 (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
20.0 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
20.0 ml
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subacromial impingement syndrome
- MRI with intact rotator cuff
- Patients suitable for general anaesthesia
Exclusion Criteria:
- Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
- Abnormal ECG
- Prolonged QT syndrome
- Current or regular use of analgesic medication for other indication(s)
Contacts and Locations
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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: NCT00993798
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993798
Locations
| Austria | |
| Nycomed Investigational Site | |
| Graz, Austria | |
| Nycomed Investigational Site | |
| Vienna, Austria, 1090 | |
| Nycomed Investigational Site | |
| Vienna, Austria, 1130 | |
| Denmark | |
| Nycomed Investigational Site | |
| Skoerping, Denmark | |
| Germany | |
| Nycomed Investigational Site | |
| Berlin, Germany | |
| Nycomed Investigational Site | |
| Dresden, Germany | |
| Nycomed Investigational Site | |
| Marburg, Germany | |
| Latvia | |
| Nycomed Investigational Site | |
| Riga, Latvia | |
| Nycomed Investigational Site | |
| Valmiera, Latvia | |
| Poland | |
| Nycomed Investigational Site | |
| Lodz, Poland | |
| Sweden | |
| Nycomed Investigational Site | |
| Stockholm, Sweden | |
Sponsors and Collaborators
Durect
Takeda
Investigators
| Study Chair: | Nycomed Clinical Trial Operations | Headquarters |
More Information
| Responsible Party: | Durect |
| ClinicalTrials.gov Identifier: | NCT00993798 History of Changes |
| Other Study ID Numbers: |
BU-002-IM |
| Study First Received: | October 9, 2009 |
| Last Updated: | January 30, 2013 |
Keywords provided by Durect:
|
Post operative pain Local anaesthesia Postoperative pain after arthroscopic shoulder surgery |
Additional relevant MeSH terms:
|
Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms |
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on August 17, 2017