Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Abdominal Surgery
Recruiting
Phase 2Phase 3Interventional Study
Postoperative Pain
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
Shanghai Huilun Pharmaceutical Co., Ltd. · Industry
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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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 proce…
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.
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