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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2009

Last Updated Date

January 30, 2013

Start Date ^ICMJE

May 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00993226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain

Intervention ^ICMJE

Drug: SABER-Bupivacaine Treatment 1a
5.0 ml
Drug: Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
Drug: Bupivacaine HCl Treatment 1c
40 ml
Drug: SABER-Bupivacaine Treatment 2a
7.5 ml
Drug: Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
Drug: Bupivacaine HCl Treatment 2c
40 ml

Study Arm (s)

Experimental: SABER-Bupivacaine Treatment 1a
double-blind

Intervention: Drug: SABER-Bupivacaine Treatment 1a
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 1b
double-blind

Intervention: Drug: Placebo SABER-Bupivacaine Treatment 1b
Active Comparator: Bupivacaine HCl Treatment 1c
double-blind

Intervention: Drug: Bupivacaine HCl Treatment 1c
Experimental: SABER-Bupivacaine Treatment 2a
double-blind

Intervention: Drug: SABER-Bupivacaine Treatment 2a
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 2b
double-blind

Intervention: Drug: Placebo SABER-Bupivacaine Treatment 2b
Active Comparator: Bupivacaine HCl Treatment 2c
double-blind

Intervention: Drug: Bupivacaine HCl Treatment 2c

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

115

Completion Date

July 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany, Hungary, Latvia, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00993226

Other Study ID Numbers ^ICMJE

BU-001-IM

Has Data Monitoring Committee

Responsible Party

Durect

Study Sponsor ^ICMJE

Durect

Collaborators ^ICMJE

Nycomed: A Takeda Company

Investigators ^ICMJE

Study Chair:

Nycomed Clinical Trial Operations

Headquarters

Information Provided By

Durect

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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