Status:
COMPLETED
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Acute Pain
Eligibility:
FEMALE
21-60 years
Phase:
PHASE2
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 hyste...
Detailed Description
Currently, the most widely used drugs to treat pain after surgery are opiates, such as morphine. Morphine works mainly by activating one of several types of opiate receptors that control some of our p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00877799
Start Date
March 1 2009
End Date
January 1 2010
Last Update
May 12 2015
Active Locations (12)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
2
Springhill Medical Center
Mobile, Alabama, United States, 36608
3
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
4
Paradise Valley Hospital
Phoenix, Arizona, United States, 85032