NCT00993226

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Durect · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2009-10-12
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

14 sites across 6 countries: France, Germany, Hungary, Latvia, Sweden, United Kingdom