Phase 2
Completed N=68
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
Source: ClinicalTrials.gov NCT00877799 ↗Enrolled (actual)
68
Serious AEs
7.9%
Results posted
May 2015
Primary outcomePrimary: Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint — 1; 1 responders
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint |
1; 1 | — |
| SECONDARY Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment |
24.0; 15.8 | 0.057 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00877799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.