A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Seve… (NCT06680466) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase â…¡ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery
China179 participantsStarted 2023-12-26
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age≥18 and ≤75 years at screening.
✓. 18.0 kg/m2≤Body mass index (BMI) ≤28.0 kg/m2
✓. American Society of Anesthesiologists (ASA) Physical Status Classification System classification â… or â…¡.
✓. 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
Exclusion criteria
✕. 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;
What they're measuring
1
The time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24)
✕. 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;