A Trial of HR021618 in Postsurgical Pain Management

NCT04699175 | Unknown Phase 2

• 1 other identifier: HR021618-202
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgical Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Usage of Morphine, Post Surgery at other intervals

  0 hour to 48 hours after IP administration

• Pain intensity assessed using an 11-point NRS ranging

  Baseline till 48 hours post IP administration

• Pain relief assessed using an 5-point likert scale

  Baseline till 48 hours post IP administration

• Time to First Dose of Rescue Analgesia

  0 hour to 48 hours after IP administration

• Frequency of Doses of Rescue Analgesia Utilized Per Subject

  0 hour to 48 hours after IP administration

Study Arms (3)

Treatment group A

EXPERIMENTAL

Drug: HR021618

Treatment group B

EXPERIMENTAL

Drug: HR021618

Treatment group C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HR021618 DRUG

Treatment group A:HR021618; high dose

Treatment group A

Placebo DRUG

Treatment group C: HR021618 blank preparation.

Treatment group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring elective Orthopaedic surgery
• Male or female
• Meet the weight standard

You may not qualify if:

• 、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
• History of major surgery
• History of active or high-risk bleeding disorders
• History of myocardial infarction or coronary artery bypass
• History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
• Abnormal values in the laboratory
• 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
• 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
• Planned/actual admission to the intensive care unit
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)
• The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR021618 compared with placebo

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: December 17, 2020
• Primary Completion: August 3, 2021
• Study Completion: August 8, 2021
• Last Updated: August 6, 2021

Record last verified: 2020-12

Locations

CN (1)