CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
CR845 +1 moredrug
Likely dose
CR845 0.005 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01789476
NCT01789476Phase 2Completed
CompareCT.gov

A Single-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of CR845 Dosed in Patients With Pain Following Bunionectomy Surgery

Cara Therapeutics, Inc.·interventional·Posted Feb 12, 2013·Updated Apr 30, 2015

In Brief

A Phase 2 clinical trial evaluating CR845 and Placebo for Acute Pain. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2013
Enrollment StartMay 1, 2013
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.4 years ago

Interventions

CR845drug

CR845 dosage = 0.005 mg/kg per dose, IV bolus. The initial dose was administered upon reaching a qualifying pain intensity score and followed by a supplemental dose, if requested by patient for pain. Additional doses could be administered every 8 hours up to 48 hours.

Placebodrug

Matching placebo administered using same dosing algorithm as the active arm