Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cara Therapeutics, Inc.
• Treatments: Analgesics; Peripheral Nervous System Agents

Criteria

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 hysterectomy alone;

• Has taken non-opioid analgesics (including cyclooxygenase-2 [COX-2] inhibitors) or nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours of the Baseline assessments;

• Has taken any opioid analgesics or used systemic steroids within 4 days of surgery OR has previously used opiates chronically for a period of ≥3 months;

• Has used antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants for < 30 days prior to surgery or had a dose change within the previous 30 days;

• Has taken any prescription or over-the-counter medication within 3 days prior to surgery that, in the opinion of the Investigator, is expected to confound the analgesic response;

• Has taken herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) 7 days prior to surgery;

• In the opinion of Investigator shows clinical signs of hypovolemia;

• Has an oxygen saturation < 92% on room air at Screening or prior to receiving the first infusion of study drug;

• Has any history of clinically significant cardiovascular disease,

• Has a clinically significant abnormal electrocardiogram (ECG) or a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);

• Has a history of any serious medical conditions that in the opinion of the Investigator would preclude study participation;

• Has serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or gamma glutamyl transferase (GGT) >2.5 x the upper limit of normal (ULN) at screening;

• Has bilirubin, blood urea nitrogen (BUN), or creatinine >1.5 x the reference ULN at Screening;

• Has abnormally low hemoglobin < 10 mg/dl at Screening;

• Has serum sodium levels > 146 mmol/L at Screening;

• Has impaired renal function (creatinine clearance [CrCl] < 50 ml/min) at Screening;

• Has a positive test for human immunodeficiency virus (HIV) or known history of HIV infection;

• Has received another investigational drug within 30 days of scheduled surgery;

• Has a significant chronic pain condition in areas unrelated to the operative site at the time of Screening that in the Investigator's opinion could confound the interpretation of study results