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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04699175
Other study ID # HR021618-202
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 17, 2020
Est. completion date August 8, 2021

Study information

Verified date December 2020
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 108
Est. completion date August 8, 2021
Est. primary completion date August 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HR021618
Treatment group A:HR021618; high dose
HR021618
Treatment group B:HR021618; low dose
Placebo
Treatment group C: HR021618 blank preparation.

Locations

Country Name City State
China Shanghai Changhai Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usage of Morphine, Post Surgery Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration. 0 hour to 24 hours after IP administration
Secondary Usage of Morphine, Post Surgery at other intervals Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration. 0 hour to 48 hours after IP administration
Secondary Pain intensity assessed using an 11-point NRS ranging 11-point NPRS ranging from a score of 0 to 10. Baseline till 48 hours post IP administration
Secondary Pain relief assessed using an 5-point likert scale 5-point likert scale from a score of 0 to 4. Baseline till 48 hours post IP administration
Secondary Time to First Dose of Rescue Analgesia Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. 0 hour to 48 hours after IP administration
Secondary Frequency of Doses of Rescue Analgesia Utilized Per Subject Rescue analgesia was available to subjects with inadequately controlled pain upon request. 0 hour to 48 hours after IP administration
Secondary Proportion of subjects who received Rescue Analgesia Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. 0 hour to 48 hours after IP administration
Secondary Patient Global Assessment (PGA) of Pain Control PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4) 0 hour to 48 hours after IP administration
See also
  Status Clinical Trial Phase
Completed NCT05769855 - A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy Phase 3
Completed NCT05376904 - A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy. Phase 2
Not yet recruiting NCT05161637 - Phase 2/3 Study of TLC590 for Postsurgical Pain Management Phase 2/Phase 3