451
Participants
Start Date
September 30, 2015
Primary Completion Date
April 30, 2018
Study Completion Date
June 30, 2018
CR845 IV 1 mcg/kg
"CR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided."
CR845 IV 0.5 mcg/kg
"CR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.~Saline infusion (IV 0.45%) for fluid replenishment will be provided."
Placebo IV
"Placebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.~Saline infusion (IV 0.45%) for fluid replenishment will be provided."
Cara Therapeutics Study Site, Durham
Cara Therapeutics Study Site, Pensacola
Cara Therapeutics Study Site, St. Petersburg
Cara Therapeutics Study Site, Bradenton
Cara Therapeutics Study Site, Salt Lake City
Cara Therapeutics Study Site, Sheffield
Cara Therapeutics Study Site, New Haven
Cara Therapeutics Study Site, Gainesville
Cara Therapeutics Study Site, Maitland
Cara Therapeutics Study Site, Miami Gardens
Cara Therapeutics Study Site, Chicago
Cara Therapeutics Study Site, Boston
Cara Therapeutics Study Site, Neptune City
Cara Therapeutics Study Site, Cleveland
Cara Therapeutics Study Site, Columbus
Cara Therapeutics Study Site, Pittsburgh
Cara Therapeutics Study Site, Chattanooga
Cara Therapeutics Study Site, Bellaire
Cara Therapeutics Study Site, Fort Worth
Cara Therapeutics Study Site, Houston
Cara Therapeutics Study Site, Plano
Cara Therapeutics Study Site, San Antonio
Cara Therapeutics Study Site, Camden
Lead Sponsor
Cara Therapeutics, Inc.
INDUSTRY