Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy S… (NCT01361568) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
United States203 participantsStarted 2011-07
Plain-language summary
The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.
Who can participate
Age range21 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Able to provide written informed consent prior to any study procedures;
* Able to communicate clearly with the Investigator and staff;
* Female between 21 and 65 years of age, inclusive;
* Scheduled for elective laparoscopic hysterectomy under general anesthesia;
* Negative result on serum pregnancy test at screening and negative urine pregnancy test at Baseline (for women of child-bearing potential only) and not currently breast feeding, or planning to do so within 30 days of dosing;
* Negative urine drug screen for drugs of abuse at Screening and at Baseline;
* American Society of Anesthesiologists (ASA) risk class of I to III;
* Body mass index (BMI) between 17 and 40 inclusive.
Exclusion Criteria:
* Has known allergies to opioids, or hypersensitivity to other materials (such as infusion line) or medications to be used in the study;
* Has a known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-diagnosed alcohol, opiate or other drug abuse or dependence within 12 months prior to screening;
* Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the Treatment Period;
* Is scheduled to undergo a hysterectomy that will utilize any type of robotic technology and/or a concomitant surgical procedure that would produce a significantly greater degree of surgical trauma than the laparoscopic hysterectomy or laparoscopic assisted vaginal hysterec…
What they're measuring
1
Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment