Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
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|ClinicalTrials.gov Identifier: NCT01361568|
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : May 19, 2014
Last Update Posted : May 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: CR845 Drug: Placebo||Phase 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Peripheral kappa opioid receptor agonist
Single i.v. dose (0.04 mg/kg) administered preoperatively
Other Name: Preoperative Active Dose
Single i.v. dose (0.04 mg/kg) administered postoperatively for pain
Other Name: Postoperative Active for Pain
Placebo Comparator: Placebo
Single i.v. dose administered preoperatively
Other Name: Preoperative Placebo Dose
Single i.v. dose administered postoperatively for pain
Other Name: Postoperative Placebo for Pain
- Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment [ Time Frame: 24 hours ]
- Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF) [ Time Frame: 0 to 24 hours ]
Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented "No Pain" and 100 mm represented the "Worst Pain You Can Imagine". SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score), then at 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 720, 960, and 1440 minutes after the start of the infusion of study drug following surgery.
Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain).
- Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU) [ Time Frame: 2 to 24 hours (post-PACU) ]
- Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF [ Time Frame: 0 to 2 hours ]
Patients reported their pain relief using a 5-point categorical scale of 0 to 4 (0 = No Relief, 1 = A Little Relief, 2 = Some Relief, 3 = A Lot of Relief and 4 = Complete Relief). TOTPAR 0-2 was represents the cumulative time-weighted sum of the pain relief (PR) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 15 to 30 min, 30 to 45 min, etc.) over the first 2 hours. Pain relief assessments were measured at 15, 30, 45, 60, 90, 120 minutes after the start of the infusion of study drug following surgery.
Positive TOTPAR values represent an increase in pain relief.
- Global Evaluation Responder Analysis [ Time Frame: At 24 hours ]Responders = Excellent or Very Good; Non-Responders = Fair or Poor. Patient who reported a score of "Good" were not included in the analysis as the midpoint cannot be unambiguously assigned for a binary outcome measurement.
- Total Number of Patients Reporting At Least One Episode of Nausea [ Time Frame: Up to 24 hours ]
- Total Number of Patients Reporting At Least One Episode of Vomiting [ Time Frame: Up to 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361568
|Principal Investigator:||Tong-Joo Gan, MD, MHS||Duke University|