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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

NCT ID: NCT00993798

Last Updated: 2021-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SABER-Bupivacaine Treatment 1a

double-blind

Group Type EXPERIMENTAL

SABER-Bupivacaine Treatment 1a

Intervention Type DRUG

5.0 ml

Placebo SABER-Bupivacaine Treatment 1b

double-blind

Group Type PLACEBO_COMPARATOR

Placebo SABER-Bupivacaine Treatment 1b

Intervention Type DRUG

5.0 ml

Bupivacaine HCl Treatment 1c

double-blind

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl Treatment 1c

Intervention Type DRUG

20.0 ml

SABER-Bupivacaine Treatment 2a

double-blind

Group Type EXPERIMENTAL

SABER-Bupivacaine Treatment 2a

Intervention Type DRUG

7.5 ml

Placebo SABER-Bupivacaine Treatment 2b

double-blind

Group Type PLACEBO_COMPARATOR

Placebo SABER-Bupivacaine Treatment 2b

Intervention Type DRUG

7.5 ml

Bupivacaine HCl Treatment 2c

double-blind

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl Treatment 2c

Intervention Type DRUG

20.0 ml

Interventions

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SABER-Bupivacaine Treatment 1a

5.0 ml

Intervention Type DRUG

Placebo SABER-Bupivacaine Treatment 1b

5.0 ml

Intervention Type DRUG

Bupivacaine HCl Treatment 1c

20.0 ml

Intervention Type DRUG

SABER-Bupivacaine Treatment 2a

7.5 ml

Intervention Type DRUG

Placebo SABER-Bupivacaine Treatment 2b

7.5 ml

Intervention Type DRUG

Bupivacaine HCl Treatment 2c

20.0 ml

Intervention Type DRUG

Other Intervention Names

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POSIMIR® bupivacaine solution

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nycomed

INDUSTRY

Sponsor Role collaborator

Durect

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nycomed Clinical Trial Operations

Role: STUDY_CHAIR

Headquarters

Locations

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Nycomed Investigational Site

Graz, , Austria

Site Status

Nycomed Investigational Site

Vienna, , Austria

Site Status

Nycomed Investigational Site

Vienna, , Austria

Site Status

Nycomed Investigational Site

Berlin, , Germany

Site Status

Nycomed Investigational Site

Dresden, , Germany

Site Status

Nycomed Investigational Site

Marburg, , Germany

Site Status

Nycomed Investigational Site

Riga, , Latvia

Site Status

Nycomed Investigational Site

Valmiera, , Latvia

Site Status

Nycomed Investigational Site

Lodz, , Poland

Site Status

Nycomed Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Austria Germany Latvia Poland Sweden

Other Identifiers

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BU-002-IM

Identifier Type: -

Identifier Source: org_study_id

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