Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: CR845; CR845; CR845; Placebo; Placebo
Intervention description: CR845 (0.024 mg/kg) administered the day after surgery (Day 1); CR845 (0.008 mg/kg) administered the day after surgery (Day 1); CR845 (0.040 mg/kg) administered immediately after surgery (Day 0); Matched placebo administered the day after surgery (Day 1); Matched placebo administered immediately after surgery (Day 0)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 114.0
Sex: Female
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
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

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).
    

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.