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The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR021618 | Drug | Treatment group A: HR021618 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC48 | Area under the pain intensity-time curve. | 48 hours after recovery from anesthesia] Area under the pain intensity-time curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of morphine over 0-48, 0-24, 24-48 hours | Total consumption of morphine after recovery from anesthesia. | 48 hours after recovery from anesthesia |
| AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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Parallel Assignment
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| Placebo |
| Drug |
Treatment group B: Saline injection |
|
Area under the pain intensity-time curve.
| 48 hours after recovery from anesthesia |
| Time of the first dose of rescue analgesia | Time of the first dose of rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia |
| Proportion of subjects receiving rescue analgesia | Proportion of subjects receiving rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia |
| Frequency of doses of rescue analgesia | Frequency of doses of rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia |
| Subjects' satisfaction rating | Subjects' satisfaction rating. | 48 hours after recovery from anesthesia |
| Anesthesiologist satisfaction rating | Anesthesiologist satisfaction rating. | 48 hours after recovery from anesthesia |