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This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-1186 | Experimental | Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses |
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| HL-1186 placebo | Placebo Comparator | Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-1186 | Drug | HL-1186 tablet for oral administration. |
| |
| HL-1186 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| SPID48 | SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score). | 0 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renhai Yang | Contact | 021-64311017 | clinical_trial@hllife.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| Drug |
HL-1186 placebo tablet for oral administration. |
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