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Phase â…¡, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR18034 | Experimental |
| |
| Ropivacaine Hydrochloride Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034 | Drug | HR18034 228mg/342mg/456mg |
| |
| Ropivacaine Hydrochloride Injection |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72 of the NRS-A (or cough) pain intensity scores. | AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration. | 0 to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the NRS-A (or cough) pain intensity scores. | AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours. | 0-12, 12-24,12-48, 12-72 hours |
| AUC of the NRS-R pain intensity scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Liu | Contact | +0518-82342973 | qin.liu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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HR18034 compared with active comparator
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| Drug |
Ropivacaine Hydrochloride Injection 60mg/90mg/120mg |
|
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours.
| 0-12, 12-24,12-48, 12-72, 0-72 hours |
| Proportion of subjects who used no rescue opioid analgesic. | Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration. | 0-24, 24-48, 48-72, 0-72 hours |
| Total rescue analgesic consumption. | Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration. | 0-24, 24-48, 48-72, 0-72 hours |
| Time to the first postoperative use of rescue opioid analgesics. | Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration. | 0-72 hours |
| Subjects' satisfaction rating | Subjects' satisfaction rating with postsurgical pain control at 72 hours. | 72 hours |
| Investigators' satisfaction rating | Investigators' satisfaction rating with postsurgical pain control at 72 hours. | 72 hours |
| D000588 |
| Amines |