A Trial of HR021618 in Postsurgical Pain Management

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04699175
Collaborator
(none)
108
1
3
7.7
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
HR021618 compared with placeboHR021618 compared with placebo
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
Actual Study Start Date :
Dec 17, 2020
Actual Primary Completion Date :
Aug 3, 2021
Anticipated Study Completion Date :
Aug 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A

Drug: HR021618
Treatment group A:HR021618; high dose

Experimental: Treatment group B

Drug: HR021618
Treatment group B:HR021618; low dose

Placebo Comparator: Treatment group C

Drug: Placebo
Treatment group C: HR021618 blank preparation.

Outcome Measures

Primary Outcome Measures

  1. Usage of Morphine, Post Surgery [0 hour to 24 hours after IP administration]

    Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.

Secondary Outcome Measures

  1. Usage of Morphine, Post Surgery at other intervals [0 hour to 48 hours after IP administration]

    Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.

  2. Pain intensity assessed using an 11-point NRS ranging [Baseline till 48 hours post IP administration]

    11-point NPRS ranging from a score of 0 to 10.

  3. Pain relief assessed using an 5-point likert scale [Baseline till 48 hours post IP administration]

    5-point likert scale from a score of 0 to 4.

  4. Time to First Dose of Rescue Analgesia [0 hour to 48 hours after IP administration]

    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.

  5. Frequency of Doses of Rescue Analgesia Utilized Per Subject [0 hour to 48 hours after IP administration]

    Rescue analgesia was available to subjects with inadequately controlled pain upon request.

  6. Proportion of subjects who received Rescue Analgesia [0 hour to 48 hours after IP administration]

    Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.

  7. Patient Global Assessment (PGA) of Pain Control [0 hour to 48 hours after IP administration]

    PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04699175
Other Study ID Numbers:
  • HR021618-202
First Posted:
Jan 7, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021