A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery

NCT06680466 | Active Not Recruiting Phase 2

• 1 other identifier: YZJ-4729-2-01
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective： To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery. Secondary Objective： To explore the analgesic efficacy and safety of YZJ-4729 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24)

  24 hours

Secondary Outcomes (4)

• The proportion of subjects who did not use rescue analgesics within 0 to 24 hours

  0~24 hours

• The time-weighted sum of differences in resting state pain intensity over different perioid

  0-24 hours

• Participant ' satisfaction score for analgesia treatment

  24 hours

• Investigator satisfaction score for analgesia treatment

  24 hours

Other Outcomes (7)

• The total dose and times of rescue analgesics

  0-24 hours

• Time of first use of rescue analgesics for the first time

  0-24 hours

• The sum of resting state pain relief score over 24 hours

  6、12、18、24、12~24 hours

Study Arms (6)

Treatment group 1

EXPERIMENTAL

Drug: YZJ-4729

Treatment group 2

EXPERIMENTAL

Drug: YZJ-4729

Treatment group 3

EXPERIMENTAL

Drug: YZJ-4729

Treatment group 4

EXPERIMENTAL

Drug: YZJ-4729

Morphine

ACTIVE COMPARATOR

Drug: morphine

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

YZJ-4729 DRUG

Dose Group 1

Treatment group 1

morphine DRUG

morphine,

Morphine

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 and ≤75 years at screening.
• kg/m2≤Body mass index (BMI) ≤28.0 kg/m2
• American Society of Anesthesiologists (ASA) Physical Status Classification System classification Ⅰ or Ⅱ.
• Scheduled to undergo abdominal surgery, and estimated duration of the surgery is between 1 hour and 6 hours.
• NRS ≥ 4 within 4 hours after after extubation of the tracheal tube.
• Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure

You may not qualify if:

• Individuals with a known history of allergy to any component of the investigational drug, or with an allergy or contraindication to anesthetic/analgesic drugs used during surgery;
• Patients with the following conditions or medical histories:
• Comorbid with stroke, Parkinson's syndrome, cognitive impairment, or a history of epilepsy (excluding convulsions caused by high fever in childhood),
• Patients with craniocerebral injury, increased intracranial pressure, or brain tumors,
• History of difficult airway, obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory system diseases, other severe respiratory system diseases, or acute upper respiratory tract infections within 2 weeks;
• History of myocardial infarction or angina within 6 months before screening, or history of severe arrhythmias such as Ⅱ or higher degree atrioventricular block, with a history of New York Heart Association (NYHA) heart function classification class II or above;
• History of vestibular dysfunction or motion sickness, or dizziness, nausea, dry retching/vomiting within 1 week before screening;
• Comorbid with gastrointestinal system motility disorders (such as reflux esophagitis) or known/suspected gastrointestinal obstruction, including paralytic gastrointestinal obstruction;
• Randomized blood glucose ≥11.1 mmol/L or glycated hemoglobin ≥9% during the screening period;
• Patients with a clear diagnosis of clinical hypothyroidism;
• Presence of other acute or chronic pain conditions before surgery or comorbid with other physical pain that could confound the evaluation of postoperative pain.
• Hypertension that has not received regular antihypertensive treatment or is poorly controlled despite treatment: during the screening period, systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg (excluding abnormalities during the peri-anesthetic period).
• Patients with a systolic blood pressure less than 90 mmHg during the screening period (excluding abnormalities during the peri-anesthetic period);
• Peripheral capillary oxygen saturation (SpO2) \<92% in a non-oxygen-supplemented state (excluding abnormalities during the peri-anesthetic period) at screening;
• Clinically significantly abnormal electrocardiogram, including a QT interval corrected for heart rate (Fridericia; QTcF interval) of \> 450 milliseconds in males and \> 470 milliseconds in females, at screening.

Sponsors & Collaborators

• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

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: Multi center, randomized, double-blind, placebo-controlled, and positive drug parallel controls

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 8, 2024
• Study Start: December 26, 2023
• Primary Completion: July 15, 2024
• Study Completion: November 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CN (1)