The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
203
Shoals Clinical Research Associates
Florence, Alabama, United States
Horizon Research Group
Mobile, Alabama, United States
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)
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).
Time frame: 0 to 24 hours
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
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.
Time frame: 0 to 2 hours
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Single i.v. dose administered postoperatively for pain
Wilmax
Mobile, Alabama, United States
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Shoals Medical Trials, INC
Sheffield, Alabama, United States
Precision Clinical Trials
Phoenix, Arizona, United States
Woodland Healthcare California Clinical Research, Inc
Davis, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
...and 8 more locations
Global Evaluation Responder Analysis
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.
Time frame: At 24 hours
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