Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment
| Group | Value (mg) | Spread |
|---|---|---|
| Placebo-Placebo | 21.9 | 1.89 |
| Placebo-CR845 | 17.6 | 1.65 |
| CR845-CR845 | 13.9 | 2.20 |
| CR845-Placebo | 19.8 | 3.03 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
NCT01361568Jul 2011 to Apr 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.
Experimental
CR845
Peripheral kappa opioid receptor agonist
Placebo comparator
Placebo
Matched Placebo
Outcomes the sponsor listed as primary.
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
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg) | Spread |
|---|---|---|
| Placebo-Placebo | 21.9 | 1.89 |
| Placebo-CR845 | 17.6 | 1.65 |
| CR845-CR845 | 13.9 | 2.20 |
| CR845-Placebo | 19.8 | 3.03 |
| Group | Value (units on a scale * hours) | Spread |
|---|---|---|
| Placebo-Placebo | -413.1 | 67.8 |
| Placebo-CR845 | -643.2 | 58.11 |
| CR845-CR845 | -833.1 | 124.8 |
| CR845-Placebo | -673.5 | 152.36 |
| Group | Value (mg) | Spread |
|---|---|---|
| Placebo-Placebo | 14.38 | 1.35 |
| Placebo-CR845 | 11.07 | 1.17 |
| CR845-CR845 | 7.99 | 2.03 |
| CR845-Placebo | 11.33 | 2.11 |
| Group | Value (units on a scale * hours) | Spread |
|---|---|---|
| Placebo-Placebo | 1.4 | 0.16 |
| Placebo-CR845 | 2.1 | 0.19 |
| CR845-CR845 | 2.4 | 0.48 |
| CR845-Placebo | 1.5 | 0.40 |
| Group | Value (Responder Count) |
|---|---|
| Placebo | 27 |
| CR845 | 68 |
| Group | Value (percentage of patients) |
|---|---|
| Placebo | 51.2 |
| CR845 | 26.1 |
| Group | Value (percentage of patients) |
|---|---|
| Placebo | 8.3 |
| CR845 | 1.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo-PlaceboPlacebo administered both preoperatively and postoperatively | – | 0 / 71 | 59 / 71 |
| Placebo-CR845Placebo administered preoperatively and CR845 administered postoperatively | – | 6 / 71 | 62 / 71 |
| CR845-CR845CR845 administered both preoperatively and postoperatively | – | 3 / 20 | 19 / 20 |
| CR845-PlaceboCR845 administered preoperatively and placebo administered postoperatively | – | 0 / 21 | 15 / 21 |
| CR845-No Postoperative TreatmentCR845 administered preoperatively and no study drug administered postoperatively | – | 3 / 7 | 7 / 7 |
| Placebo-No Postoperative TreatmentPlacebo administered preoperatively and no study drug administered postoperatively | – | 1 / 13 | 10 / 13 |
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