At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SABER-Bupivacaine Treatment 1a, Placebo SABER-Bupivacaine Treatment 1b, and 4 other interventions for Postoperative Pain. Completed, enrolled 115 participants across 14 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
5.0 ml
5.0 ml
40 ml
7.5 ml
7.5 ml
40 ml