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

NCT00993226 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-06-01

Study results available
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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.

Conditions

  • Postoperative Pain

Interventions

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

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY

  • Durect

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquarters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-12-31
Completion
2010-07-31

Countries

  • France
  • Germany
  • Hungary
  • Latvia
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993226 on ClinicalTrials.gov