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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

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ClinicalTrials.gov Identifier: NCT00993798
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Durect

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity (PI) [ Time Frame: 0-3 days after surgery ]
  2. Supplemental opioid use [ Time Frame: 0-3 days after surgery ]

Secondary Outcome Measures :
  1. Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ]
  2. Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993798


Locations
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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
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Study Chair: Nycomed Clinical Trial Operations Headquarters
More Information
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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT00993798     History of Changes
Other Study ID Numbers: BU-002-IM
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013
Keywords provided by Durect:
Post operative pain
Local anaesthesia
Postoperative pain after arthroscopic shoulder surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents