Clinical trial NCT04699175: A Trial of HR021618 in Postsurgical Pain Management
Official title: A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postsurgical Pain Management
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR021618 compared with placebo
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective Orthopaedic surgery
3. Male or female
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria

1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery

Exclusion Criteria:

1. History of major surgery
2. History of active or high-risk bleeding disorders
3. History of myocardial infarction or coronary artery bypass
4. History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
5. Abnormal values in the laboratory
6. Have a known allergy 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
7. 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
8. Planned/actual admission to the intensive care unit
9. Pregnant or nursing women
10. No birth control during the specified period of time
11. Participated in clinical trials of other drugs (received experimental drugs)
12. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: Usage of Morphine, Post Surgery
timeFrame: 0 hour to 24 hours after IP administration
Secondary outcomes:
measure: Usage of Morphine, Post Surgery at other intervals
timeFrame: 0 hour to 48 hours after IP administration
measure: Pain intensity assessed using an 11-point NRS ranging
timeFrame: Baseline till 48 hours post IP administration
measure: Pain relief assessed using an 5-point likert scale
timeFrame: Baseline till 48 hours post IP administration
measure: Time to First Dose of Rescue Analgesia
timeFrame: 0 hour to 48 hours after IP administration
measure: Frequency of Doses of Rescue Analgesia Utilized Per Subject
timeFrame: 0 hour to 48 hours after IP administration
measure: Proportion of subjects who received Rescue Analgesia
timeFrame: 0 hour to 48 hours after IP administration
measure: Patient Global Assessment (PGA) of Pain Control
timeFrame: 0 hour to 48 hours after IP administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
Study officials:
References: