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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Pain

In brief

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).

Key facts

Study ID

NCT00877799

Run by

Cara Therapeutics, Inc.

People needed

114

Starts

2009-03-01

Expected to finish

2010-01-01

Last updated by the study team

2015-05-12

Who can join

Age: 21 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Springhill Medical Center — Mobile, Alabama, United States
• Helen Keller Hospital — Sheffield, Alabama, United States
• Paradise Valley Hospital — Phoenix, Arizona, United States
• Adventist Medical Center — Glendale, California, United States
• Saddleback Memorial Hospital — Laguna Hills, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Palms West Hospital — Loxahatchee Groves, Florida, United States
• University of Miami/Jackson Memorial Hospital — Miami, Florida, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Memorial Hermann - Memorial City Medical Center — Houston, Texas, United States
• The Woman's Hospital of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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