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Tests treatment safety and results for Pain After Abdominal Surgery
Official title Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain
ClinicalTrials.gov ID: NCT07491146
What this study is testing
What is Low dose HSK55718?
Low dose HSK55718 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain after abdominal surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fully understand, voluntarily participate in this study and sign the informed consent;
- Age ≥18 years old, both sexes;
- Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
- 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;
You likely can't join if
- 1\. Disease status
- History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
- Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina...
- Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe...
- History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular...
- cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria: (1) Blood...
See the full eligibility criteria
- Fully understand, voluntarily participate in this study and sign the informed consent;
- Age ≥18 years old, both sexes;
- Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
- 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
- American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;
- NRS≥4 in the resting state at any time within 4 hours after the end of surgery;
- Be able to comply with the follow-up schedule and other program requirements;
- Participants agreed to use highly effective contraception for the entire duration of the study, from the time they signed the ICF until 3 months after the last dose of the investigational product was administered.
- 1\. Disease status
- History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
- Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe...
- Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear...
- History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of...
- cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria: (1) Blood routine: white blood cell count \ 2×ULN; Total bilirubin \> 2×ULN...
- Patients with a history of severe drug allergy, or other drugs that may be used during the trial, such as anesthetics propofol/sevoflurane, rocuronium, antiemetic drugs, or drugs and their excipients;
- Taking opioid analgesics for any reason for more than 10 consecutive days within 3 months before randomization;
- Drugs that may affect the evaluation of how well it works if the time interval between the last administration of the drug and randomization is less than five half-lives of the drug, including but not limited to the...
- Use of a strong inducer or inhibitor of CYP3A within 14 days or 5 half-lives before the first dose of the investigational drug, whichever is longer; 4: Others (1) Having a history of drug abuse, drug abuse and/or...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Chengdu, Sichuan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.