Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery

NCT00877799 | Completed Phase 2 Results

• 1 other identifier: CR845-CLIN2001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts with subjects either dosed with study drug the day following surgery (Cohort 1), or immediately after surgery (Cohort 2).

Conditions

Acute 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)

• Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint

  The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of "some," "a lot," or "complete" at 15 and 30 min following the start of the study drug infusion.

  15 and 30 minutes after study drug administration

Secondary Outcomes (1)

• Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment

  0 to 16 hours

Other Outcomes (2)

• Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment

  4 to 8 hours

• Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment

  8 to 16 hours

Study Arms (2)

CR845

EXPERIMENTAL

CR845 administered as a single 15-min i.v. infusion at doses of 0.008 or 0.024 mg/kg on the day after surgery (Cohort 1), or at a dose of 0.040 mg/kg immediately after surgery (Cohort 2)

Drug: CR845

Placebo

PLACEBO COMPARATOR

Matched placebo administered as a single 15-min i.v. infusion on the day after surgery (Cohort 1), or the immediately after surgery (Cohort 2)

Drug: Placebo

Interventions

CR845 DRUG

CR845 (0.024 mg/kg) administered the day after surgery (Day 1)

Also known as: Cohort 1: CR845 0.024 mg/kg

CR845

Placebo DRUG

Matched placebo administered the day after surgery (Day 1)

Also known as: Cohort 1: Matched placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patients will have an elective laparoscopic-assisted hysterectomy under general anesthesia.
• The patient's preoperative health is graded as the American Society of Anesthesiologists (ASA) risk class of I to III

You may not qualify if:

• The patient has a history of known allergies to opioids
• The patient is currently taking opioid analgesics chronically or took opioid analgesics on at least 4 days during the week before surgery.
• Patients having additional procedures (such as those involving the bladder) at the same time as the laparoscopic-assisted hysterectomy.
• Patients taking short-acting oral analgesics (eg, acetaminophen, aspirin, ibuprofen, ketorolac) within 6 hours before administration of study drug; long-acting nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, naproxen, oxaprozin, piroxicam, celecoxib) within 3 days before administration of study drug; systemic steroids within 72 hours before administration of study drug; or any opioid analgesics or tramadol daily for greater than 10 days of the last 30 days before administration of study drug.
• Patients taking the following herbal agents or nutraceuticals within 7 days prior to beginning of the study: chaparral, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian.
• Patients with clinically significant cardiovascular disease, or cardiac arrhythmias, or significant major risk factors for cardiovascular disease such as poorly controlled hypertension, poorly controlled hypercholesterolemia, poorly controlled diabetes mellitus or serious medical conditions, such as cancer.
• Patient has a history of hepatitis B or C or HIV infection with positive hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody test.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (12)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Springhill Medical Center

Mobile, Alabama, 36608, United States

Location

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Paradise Valley Hospital

Phoenix, Arizona, 85032, United States

Location

Adventist Medical Center

Glendale, California, 91206, United States

Location

Saddleback Memorial Hospital

Laguna Hills, California, 92653, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Palms West Hospital

Loxahatchee Groves, Florida, 33472, United States

Location

University of Miami/Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Memorial Hermann - Memorial City Medical Center

Houston, Texas, 77024, United States

Location

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain; Visceral Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain

Results Point of Contact

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

fmenzaghi@caratherapeutics.com

203-567-1502

Study Officials

• Frédérique Menzaghi, Ph.D.

  Cara Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 8, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

US (12)