Clinical trial NCT04811053: HR021618 in Moderate to Severe Pain After Abdominal Surgery
Official title: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain After Abdominal Surgery
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal surgery
3. Male or female
4. Meet BMI standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of abdominal surgery
2. Subjects had hemorrhagic disorders
3. Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
4. Subjects with poor blood pressure control after medication
5. Abnormal QTc
6. Abnormal random blood glucose
7. Abnormal values in the laboratory
8. Allergic to meloxicam or any excipient of HR021618, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
9. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Participated in clinical trials of other drugs (received experimental drugs)
13. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: AUC48
timeFrame: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.
Secondary outcomes:
measure: Total consumption of morphine over 0-48, 0-24, 24-48 hours
timeFrame: 48 hours after recovery from anesthesia
measure: AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48
timeFrame: 48 hours after recovery from anesthesia
measure: Time of the first dose of rescue analgesia
timeFrame: 48 hours after recovery from anesthesia
measure: Proportion of subjects receiving rescue analgesia
timeFrame: 48 hours after recovery from anesthesia
measure: Frequency of doses of rescue analgesia
timeFrame: 48 hours after recovery from anesthesia
measure: Subjects' satisfaction rating
timeFrame: 48 hours after recovery from anesthesia
measure: Anesthesiologist satisfaction rating
timeFrame: 48 hours after recovery from anesthesia
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: