NCT01361568

Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery

A Multi-Center, Double-Randomized, Double Blind, Placebo Controlled Study to Evaluate the Analgesic Efficacy and Safety of Intravenous CR845 Dosed Preoperatively and Postoperatively in Patients Undergoing a Laparoscopic Hysterectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.

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

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	CR845	Single i.v. dose (0.04 mg/kg) administered preoperatively
DRUG	Placebo	Single i.v. dose administered preoperatively
DRUG	CR845	Single i.v. dose (0.04 mg/kg) administered postoperatively for pain
DRUG	Placebo	Single i.v. dose administered postoperatively for pain

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-05-27
• Last updated: 2014-05-29
• Results posted: 2014-05-19

Locations

18 sites across 1 country: United States