HSK55718 dose level 1
DrugPatients administrated with HSK55718 at dose level 1
NCT Number: NCT07551739
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery under general anesthesia; Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; Fully understand and voluntarily participate this trial, and sign the informed consent form;
Exclusion criteria
A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
Clinically significant abnormalities in laboratory tests during the screening period.
A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.
Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Patients administrated with HSK55718 at dose level 1
Patients administrated with HSK55718 at dose level 2
Patients administrated with HSK55718 at dose level 3
Patients administrated with placebo
Patients administrated with morphine
Time frame: 48hours
Time frame: 0-12 hours, 12-24 hours, 24 hours, 24-48 hours
Time frame: 48 hours
Time frame: 0-48 hours
Time frame: 48 hours
Contact information is provided by the study sponsor or research team.
Haisco Pharmaceutical Group Co., Ltd.
Industry
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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