Acute Pain Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Analgesic Efficacy and Safety of Intravenous CR845 During the Post-Operative Period in Subjects Undergoing Laparoscopic-Assisted Hysterectomy
Verified date | April 2015 |
Source | Cara Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 114 |
Est. completion date | January 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Medical Center | Columbus | Ohio |
United States | Adventist Medical Center | Glendale | California |
United States | Memorial Hermann - Memorial City Medical Center | Houston | Texas |
United States | The Woman's Hospital of Texas | Houston | Texas |
United States | Saddleback Memorial Hospital | Laguna Hills | California |
United States | Palms West Hospital | Loxahatchee | Florida |
United States | University of Miami/Jackson Memorial Hospital | Miami | Florida |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Springhill Medical Center | Mobile | Alabama |
United States | Huntington Memorial Hospital | Pasadena | California |
United States | Paradise Valley Hospital | Phoenix | Arizona |
United States | Helen Keller Hospital | Sheffield | Alabama |
Lead Sponsor | Collaborator |
---|---|
Cara Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment | 4 to 8 hours | No | |
Other | Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment | 8 to 16 hours | No | |
Primary | 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 | No |
Secondary | Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment | 0 to 16 hours | No |
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