A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery

Phase 2 Completed 51 enrolled Cara Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.

Timeline

Start: 2013-05
Primary completion: 2013-08
Completion: 2013-08

Outcome

Met primary endpoint

registry Placebo vs CR845; p <0.05; ANOVA NCT01789476 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difelikefalin	Protein / enzyme biologic	0.005 mg/kg	Intravenous

Indications

No indication recorded.