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

NCT01361568 | Completed Phase 2 Results

• 1 other identifier: CR845 CLIN2002
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Postoperative Pain

Keywords

pain; acute pain; visceral pain; kappa agonist; opioid analgesics; peripheral nervous system agents; physiological effects of drugs; surgery; hysterectomy; post-operative; post-operative complications

Outcome Measures

Primary Outcomes (1)

• Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment

  24 hours

Secondary Outcomes (6)

• Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF)

  0 to 24 hours

• Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU)

  2 to 24 hours (post-PACU)

• Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF

  0 to 2 hours

• Global Evaluation Responder Analysis

  At 24 hours

• Total Number of Patients Reporting At Least One Episode of Nausea

  Up to 24 hours

Study Arms (2)

CR845

EXPERIMENTAL

Peripheral kappa opioid receptor agonist

Drug: CR845

Placebo

PLACEBO COMPARATOR

Matched Placebo

Drug: Placebo

Interventions

CR845 DRUG

Single i.v. dose (0.04 mg/kg) administered preoperatively

Also known as: Preoperative Active Dose

CR845

Placebo DRUG

Single i.v. dose administered preoperatively

Also known as: Preoperative Placebo Dose

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (18)

Shoals Clinical Research Associates

Florence, Alabama, 35630, United States

Location

Horizon Research Group

Mobile, Alabama, 36606, United States

Location

Wilmax

Mobile, Alabama, 36608, United States

Location

Drug Research and Analysis Corp

Montgomery, Alabama, 36106, United States

Location

Shoals Medical Trials, INC

Sheffield, Alabama, 35660, United States

Location

Precision Clinical Trials

Phoenix, Arizona, 85032, United States

Location

Woodland Healthcare California Clinical Research, Inc

Davis, California, 95616, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

University of Miami, Dept of

Miami, Florida, 33136, United States

Location

Cypress Medical Research

Wichita, Kansas, 67226, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical, Dept of Anesthesia

Columbus, Ohio, 43210, United States

Location

Palmetto Clinical Research,

Greenville, South Carolina, 29615, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

Texas Health Care, PLLC

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Acute Pain; Visceral Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Nociceptive Pain

Results Point of Contact

• Title: Frédérique Menzaghi, PhD; Vice President, Research & Development
• Organization: Cara Therapeutics

fmenzaghi@caratherapeutics.com

203-567-1502

Study Officials

• Tong-Joo Gan, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 27, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 29, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-05

Locations

US (18)