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Tests treatment safety and results for Pain After Surgery
Official title A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery
ClinicalTrials.gov ID: NCT07533786
What this study is testing
What is HSK55718 dose level1?
HSK55718 dose level1 is an investigational medicine, being studied as a potential treatment for pain after 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
- This is a multi-center, randomized, double-blind, double-dummy, placebo/active-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.
- 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
- 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;
You likely can't join if
- 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.
See the full eligibility 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;
- 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.
- people with any other factor considered by the investigator to be ineligible for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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.