Pain
Conditions
Interventions
Phase IIb experimental Group 1:HBW-004285 tablets were administered orally at a dose of 400mg every 12 hours for a total of 4 times
Phase IIb experimental Group 2:HBW-004285 tablets 800mg were given orally every 24 hours for 2 times
Phase IIb experimental Group 3:The first dose was 1200mg, followed by 600mg on the second day after an interval of 24 hours
Phase IIb positive control group:Acetaminophen and hydrocodone tablets (5mg/325mg) were administered every 6 hours for 2 days
Phase IIb Placebo control group :Oral placebo
Phase III HBW-004285 group:Oral HBW-004285
Phase III positive control group :Acetaminophen and hydrocodone tablets (5mg/325mg) were administered every 6 hours for 2 days
PPhase III placebo control group:Oral placebo
Sponsors
The Third Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are able to understand the procedures and methods of this clinical trial (including pain intensity assessment methods), and are fully informed, voluntarily participate and sign the informed consent form; 2. When signing the informed consent form, 18=4 points.
Exclusion criteria
Exclusion criteria: 1. Suffering from other painful diseases (including frequent migraine or other types of headache) or having any history of paresthesia, which in the opinion of the investigator may confound the subject's assessment of postoperative pain; 2. History of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1)History or family history of congenital long QT syndrome or mean QTcF at screening period >=470 ms (females) or >=450 ms (males) (corrected QT interval formula using Fridericia's method, see Appendix 5 for details); (2)Ventricular arrhythmias, grade II and above atrioventricular block requiring clinical intervention; (3)Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events within 6 months (180 days) before surgery; (4)New York Heart Association (NYHA) cardiac function classification >=III. (see Appendix 6 for details); (5)Subjects with treated poorly controlled hypertension within 1 month (30 days) prior to the first dose with systolic blood pressure > 160mmHg and/or diastolic blood pressure >100mmHg (except perioperative); 3. Laboratory examination findings during the screening period (1)Abnormal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or total bilirubin =1.5× upper limit of normal (ULN); (2)Abnormal renal function: serum creatinine (Cr)>=1.5×ULN; (3)Diabetic subjects whose blood glucose is not satisfactorily controlled (fasting blood glucose >=11.1mmol/L during the screening period); (4)Anemia (Hb<90g/L); (5)Platelet count less than 50×10^9/L; (6)Abnormal coagulation function: PT prolongation above the upper limit of normal for 3 seconds and/or prolongation of APTT above the upper limit of normal for 10 seconds; 4. Patients with active gastrointestinal ulcers, significant vomiting, chronic diarrhea, intestinal obstruction, malabsorption, or other diseases known to significantly affect drug absorption, distribution, metabolism, or excretion; 5. Subjects with high risk of bleeding, including subjects with congenital bleeding disorders (such as hemophilia), subjects with abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or subjects with active bleeding, and those who are judged by the investigator to be unsuitable for this trial; 6. Those who have a history of difficult airway or severe respiratory diseases, such as obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory diseases, other serious respiratory diseases, or acute upper respiratory tract infection within 2 weeks, etc., and are judged by the investigator to be unsuitable for this study; 7. Those who have undergone any surgery 1 month before the first dose of study drug (except gastroenteroscopy, hysteroscopy, cystoscopy); 8. Presence of any of the following infectious diseases: (1)Those who test positive for human immunodeficiency virus antibody (HIV-Ab); (2)Hepatitis B virus surface antigen (HBsAg) positive; (3)Positive for hepatitis C virus antibody (HCV-Ab); (4)Those who test positive for Treponema pallidum antibody (TP-Ab); 9. Known history of allergy to any component of the investigational drug, or allergy or contraindication to anesthetic/analgesic drugs used in surgery; 10. Use of other drugs that affect the analgesic effect before randomization (except for drugs that can be used accordin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of pain intensity difference at resting between 0 and 48 hours after the first dose (SPIDr0-48); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs);Sum of pain intensity difference at resting between 0-12h, 0-24h, 0-36h, and 6-48h (SPIDr0-12SPIDr0-24SPIDr0-36SPIDr6-48);Sum of pain intensity difference during movement;Time to decrease =2 points from baseline in NRS pain score;Duration of pain relief;Time to first receipt of rescue therapy;Proportion receiving rescue therapy for the first time;The total amount of rescue medication;Satisfaction of subjects; | — |
Countries
China
Contacts
Public ContactWen Ouyang, Saiying Wang/ Mengchang Yang
The Third Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital
Outcome results
None listed