Clinical trial NCT05470075: A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.
Official title: A Multicenter, Randomized, Double-blind, Dose Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score reaches the inclusion criteria within 4 hours after the surgery.
4. Willing to comply with the study procedures and requirements.
5. Willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. Subjects who have used other drugs that have the analgesic effect.
2. Subjects who have used any drug that affect the efficacy and safety of study drug.
3. Subjects who have infection or other complications on the planned oral surgical site.
4. Subjects with hypertension or hypotension during screening period.
5. Subjects with severe cardiovascular and cerebrovascular diseases.
6. Subjects with severe gastrointestinal disease.
7. Subjects with Respiratory diseases.
8. Subjects with a history of seizure, or drug or alcohol abuse.
9. Subjects with significant abnormal electrocardiogram result.
10. Subjects with significant abnormal laboratory value.
11. Subject who were allergic to the study drug and ingredients.
12. Pregnancy, lactation or having recent pregnant plan.
13. Subjects who participated in other clinical research study 30 days before entering this study.
14. Other conditions unsuitable for participation in the study.

Primary outcomes:
measure: 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
timeFrame: 0-4 hours after drug administration
Secondary outcomes:
measure: 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
timeFrame: 0 - 6 hours, 8 hours and 12 hours after drug administration
measure: 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
timeFrame: 0-12 hours after drug administration
measure: 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
timeFrame: 0-12 hours after drug administration
measure: 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)
timeFrame: 0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration
measure: 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
timeFrame: 0-12 hours after drug administration
measure: Time from drug administration to the first NRS score≤3
timeFrame: 0-12 hours after drug administration
measure: Time from drug administration to the first use of rescue medication
timeFrame: 0-12 hours after drug administration
measure: Proportion of subjects who receive rescue therapy during the treatment period
timeFrame: 0-12 hours after drug administration]
measure: 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)
timeFrame: 12 hours after drug administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology Sichuan University
state: Sichuan
Study officials:
References: