drugset / Trial / NCT01361568

Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery

NCT01361568 ↗

Phase 2 Completed 203 enrolled Cara Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.

Timeline

Start
2011-07
Primary completion
2012-04
Completion
2012-04

Outcome

Met primary endpoint

registry Placebo-Placebo vs CR845-CR845; p <0.05; Mean Difference (Final Values) -7.96 (95% CI -15.14 to -0.78); t-test, 2 sided NCT01361568 ↗

Drugs

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

Indications

No indication recorded.