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
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).
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 pain sensation - the so-called mu opiate receptors. These receptors are
located in many areas of the brain and also outside of the brain. By activating these
receptors, morphine provides significant pain relief, but also causes side effects that
limit its use. Some of these side effects include: respiratory depression or arrest (slowed
or stopped breathing), sedation (a state of calmness or extreme relaxation), euphoria (an
exaggerated feeling of physical and mental well-being), constipation, nausea, vomiting, and
drug addiction.
In order to avoid the side effects of morphine and other mu opiates, the present
experimental drug CR845 was designed to work at a different type of opiate receptor - called
kappa - that can also provide pain relief, by acting on sensory nerves outside the brain.
CR845 was designed to penetrate the brain much less than other opiate drugs, which should
result in pain relief similar to that of morphine, but with fewer side effects. Because
CR845 activates kappa receptors instead of mu receptors, the side effects are different than
with a morphine-type drug. In particular, kappa opiates, such as CR845, do not cause
respiratory depression or arrest, euphoria, constipation, drug tolerance, physical drug
dependence or drug addiction. For these reasons, CR845 may present a distinct advantage over
other opiates that are currently used for pain relief and post-operative pain in particular.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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