drugset / Trial / NCT00877799

Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery

NCT00877799 ↗

Phase 2 Completed 114 enrolled Cara Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts with subjects either dosed with study drug the day following surgery (Cohort 1), or immediately after surgery (Cohort 2).

Timeline

Start
2009-03
Primary completion
2009-12
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Difelikefalin Protein / enzyme biologic 0.008 mg/kg Intravenous
Subject Difelikefalin Protein / enzyme biologic 0.024 mg/kg Intravenous
Subject Difelikefalin Protein / enzyme biologic 0.04 mg/kg Intravenous

Indications

No indication recorded.