NCT00877799

Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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).

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 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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	CR845	CR845 (0.024 mg/kg) administered the day after surgery (Day 1)
DRUG	CR845	CR845 (0.008 mg/kg) administered the day after surgery (Day 1)
DRUG	CR845	CR845 (0.040 mg/kg) administered immediately after surgery (Day 0)
DRUG	Placebo	Matched placebo administered the day after surgery (Day 1)
DRUG	Placebo	Matched placebo administered immediately after surgery (Day 0)

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-04-08
• Last updated: 2015-05-12
• Results posted: 2015-05-12

Locations

12 sites across 1 country: United States