Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HL-1186, HL-1186 placebo.
- Who it may be relevant to
- Registry conditions: Moderate to Severe Acute Postoperative Pain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱa Study to Evaluate the Safety and Efficacy of HL-1186 Tablets for Postoperative Pain Management in Abdominal Surgery
Overview
This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.
Interventions
- Drug HL-1186
HL-1186 tablet for oral administration. - Drug HL-1186 placebo
HL-1186 placebo tablet for oral administration.
Primary outcome measures
- SPID48 [Time frame: 0 to 48 hours]
Secondary outcome measures (1)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Day 1 to Day 30]
Eligibility criteria
Inclusion criteria
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo abdominal surgeries under general anesthesia.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
Exclusion criteria
- Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
- Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
- Unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block), New York Heart Association (NYHA) class III or higher cardiac function, recurrent asthma, etc., within screen period, and deemed ineligible per investigator's judgments.
- High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet function abnormalities), active bleeding, etc., and deemed ineligible per investigator's judgments.
- For female participants: Pregnant or lactating (within 1 year postpartum).
- Participants with childbearing potential planning conception/sperm/egg donation within 6 months post-treatment, or unwilling to use effective contraception (abstinence, barrier methods, oral contraceptives, intrauterine device, or sterilization).
- Judgment by the investigator that the participant should not enter the study due to other conditions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07311369 · PY-HL-1186-AS-Ⅱa-01