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This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-1186 High-Dose Group | Experimental | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
|
| HL-1186 Low-Dose Group | Experimental | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
|
| Oxycodone-Acetaminophen Group | Active Comparator | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
|
| Placebo Group | Placebo Comparator | Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-1186 | Drug | HL-1186 tablet for oral administration. |
|
| 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 | 0-9 days |
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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 |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
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| HL-1186 placebo | Drug | HL-1186 placebo tablet for oral administration. |
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| Oxycodone-Acetaminophen | Drug | Oxycodone-Acetaminophen for oral adminstration. |
|
| Oxycodone-Acetaminophen Matching Placebo | Drug | Oxycodone-Acetaminophen Matching Placebo for oral adminstration. |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
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