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The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR021618 | Drug | Treatment group A:HR021618; high dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration. | 0 hour to 24 hours after IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Morphine, Post Surgery at other intervals | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration. | 0 hour to 48 hours after IP administration |
| Pain intensity assessed using an 11-point NRS ranging |
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Inclusion Criteria:
1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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HR021618 compared with placebo
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| HR021618 |
| Drug |
Treatment group B:HR021618; low dose |
|
| Placebo | Drug | Treatment group C: HR021618 blank preparation. |
|
11-point NPRS ranging from a score of 0 to 10. |
| Baseline till 48 hours post IP administration |
| Pain relief assessed using an 5-point likert scale | 5-point likert scale from a score of 0 to 4. | Baseline till 48 hours post IP administration |
| Time to First Dose of Rescue Analgesia | Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. | 0 hour to 48 hours after IP administration |
| Frequency of Doses of Rescue Analgesia Utilized Per Subject | Rescue analgesia was available to subjects with inadequately controlled pain upon request. | 0 hour to 48 hours after IP administration |
| Proportion of subjects who received Rescue Analgesia | Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. | 0 hour to 48 hours after IP administration |
| Patient Global Assessment (PGA) of Pain Control | PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4) | 0 hour to 48 hours after IP administration |