A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2018

Study Completion Date

June 30, 2018

Conditions
Post Abdominal Surgery Pain
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (23)

27710

Cara Therapeutics Study Site, Durham

32503

Cara Therapeutics Study Site, Pensacola

33713

Cara Therapeutics Study Site, St. Petersburg

34209

Cara Therapeutics Study Site, Bradenton

84124

Cara Therapeutics Study Site, Salt Lake City

Unknown

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

08103

Cara Therapeutics Study Site, Camden

Sponsors
All Listed Sponsors
lead

Cara Therapeutics, Inc.

INDUSTRY