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

NCT00877799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2015-05-12

Study results available
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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).

Conditions

  • Acute Pain

Interventions

DRUG

CR845

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

DRUG

CR845

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

DRUG

CR845

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

DRUG

Placebo

Matched placebo administered the day after surgery (Day 1)

DRUG

Placebo

Matched placebo administered immediately after surgery (Day 0)

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frédérique Menzaghi, Ph.D. · Cara Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877799 on ClinicalTrials.gov