Last updated on June 2018

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


Brief description of study

The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.

Detailed Study Description

Patients will be admitted to the surgical center on the day of their abdominal surgery (Day 1, unless admission the night before is required). All patients will be seen by the study staff to confirm eligibility, review study procedures, and conduct all pre-surgical assessments required for randomization.

Qualified patients will be randomized into 1 of 3 treatment groups, corresponding to 1 of 2 dose levels of intravenous (IV) CR845 (0.5 or 1 mcg/kg) or matched placebo, respectively.

Study drug will be administered every 6 hours during the 24-hour post-operative treatment period following these initial 2 drug administrations:

  • Pre-Operative dose: Within one hour prior to anesthetic induction for surgery. This dose will be a 2X loading dose.
  • Baseline post-operative dose: within 30-minutes of being considered stable in the Post-Anesthesia Care Unit (PACU)

Subsequent dosing will be administered at 6, 12 and 18 hours.

During the Treatment and Observation Period, pain intensity scores will be obtained at specified time points and episodes of nausea or vomiting will be recorded. Upon request, patients may be provided with analgesic or anti-nausea rescue medication (restricted to morphine (if tolerated), and ondansetron, respectively) at any time after the Baseline dose of study drug is administered.

Blood sampling and safety assessments will be conducted during this period as well.

Patients will remain in the hospital until Day 3 (48-hours after surgery) at which point they will be evaluated for discharge. A follow-up medical evaluation will be scheduled within 7 - 10 days post-surgery.

Clinical Study Identifier: NCT02542384

Contact Investigators or Research Sites near you

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Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Sheffield, AL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
New Haven, CT United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Bradenton, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Gainesville, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Maitland, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Miami Gardens, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Pensacola, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Saint Petersburg, FL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Chicago, IL United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Boston, MA United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Camden, NJ United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Neptune City, NJ United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Durham, NC United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Cleveland, OH United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Columbus, OH United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Pittsburgh, PA United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Chattanooga, TN United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Bellaire, TX United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Fort Worth, TX United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Houston, TX United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Plano, TX United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
San Antonio, TX United States

Paul Windt, PharmD, MBA

Cara Therapeutics Study Site
Salt Lake City, UT United States