Not provided
Not provided
Not provided
Not provided
Not provided
The sponsor's R&D strategy is adjusted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental A: HR18042 175mg | Experimental |
| |
| Experimental B: HR18042 225mg | Experimental |
| |
| Experimental C: HR18042 275mg | Experimental |
| |
| Active Drug Comparatorļ¼Tramadol hydrochloride SR Tablets 100mg | Active Comparator |
| |
| Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18042 tablets | Drug | Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 4 hours after drug administration | 0-4 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 6 hours, 8 hours and 12 hours after drug administration | 0 - 6 hours, 8 hours and 12 hours after drug administration | |
| the Differences of Pain Intensity (PID) from each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Stomatology Sichuan University | Chengdu | Sichuan | 610041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial
Not provided
Not provided
Not provided
| HR18042 tablets | Drug | Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral |
|
| HR18042 tablets | Drug | Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral |
|
| Tramadol hydrochloride SR Tablets | Drug | Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral |
|
| Placebos | Drug | Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral |
|
| 0-12 hours after drug administration |
| Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration | 0-12 hours after drug administration |
| Sum of pain relief degree using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR) | 0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration |
| Proportion of subjects who reach a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint | 0-12 hours after drug administration |
| Time from drug administration to the first NRS scoreā¤3 | 0-12 hours after drug administration |
| Time from drug administration to the first use of rescue medication | 0-12 hours after drug administration |
| Proportion of subjects who receive rescue therapy during the treatment period | 0-12 hours after drug administration] |
| Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction) | 12 hours after drug administration |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided