CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 114 enrolled
Drug / intervention
CR845 +4 moredrug
Likely dose
CR845 0.024 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/NCT00877799
NCT00877799Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Analgesic Efficacy and Safety of Intravenous CR845 During the Post-Operative Period in Subjects Undergoing Laparoscopic-Assisted Hysterectomy

Cara Therapeutics, Inc.·interventional·Posted Apr 8, 2009·Updated May 12, 2015

In Brief

A Phase 2 clinical trial evaluating CR845 and Placebo for Acute Pain. Completed, enrolled 114 participants across 12 sites.

Detailed 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).

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2009
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.2 years ago

Interventions

CR845drug

CR845 (0.024 mg/kg) administered the day after surgery (Day 1)

CR845drug

CR845 (0.008 mg/kg) administered the day after surgery (Day 1)

CR845drug

CR845 (0.040 mg/kg) administered immediately after surgery (Day 0)

Placebodrug

Matched placebo administered the day after surgery (Day 1)

Placebodrug

Matched placebo administered immediately after surgery (Day 0)