NCT07709598 Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Abdominal Surgery
| NCT ID | NCT07709598 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Huilun Pharmaceutical Co., Ltd. |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 330 participants in total. It began in 2026-05-11 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery.
Eligibility Criteria
Inclusion Criteria: 1. 18 years old ≤ age ≤ 75 years old, gender is not limited. 2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2. 3. Scheduled to undergo abdominal surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity. 4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers. 5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4. Exclusion Criteria: 1. Previous surgery on the same site that may affect pain perception at the surgical site. 2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment. 3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment. 4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator. 5. Poorly controlled hypertension. 6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator. 7. Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances. 8. Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody. 9. Women who are pregnant or breastfeeding (within 1 year after delivery). 10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention. 11. Any other condition considered unsuitable for participation by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07709598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07709598 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07709598 currently recruiting?
Yes, NCT07709598 is actively recruiting participants. Contact the research team at clinical_trial@hllife.com.cn for enrollment information.
Where is the NCT07709598 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07709598 clinical trial?
NCT07709598 is sponsored by Shanghai Huilun Pharmaceutical Co., Ltd.. The trial plans to enroll 330 participants.