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Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery

NCT ID: NCT07311369

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate to Severe Acute Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HL-1186

Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses

Group Type EXPERIMENTAL

HL-1186

Intervention Type DRUG

HL-1186 tablet for oral administration.

HL-1186 placebo

Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses

Group Type PLACEBO_COMPARATOR

HL-1186 placebo

Intervention Type DRUG

HL-1186 placebo tablet for oral administration.

Interventions

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HL-1186

HL-1186 tablet for oral administration.

Intervention Type DRUG

HL-1186 placebo

HL-1186 placebo tablet for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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 surgeries under general anesthesia.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.

Exclusion Criteria

1. Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
2. Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
3. 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.
4. 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.
5. For female participants: Pregnant or lactating (within 1 year postpartum).
6. 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).
7. Judgment by the investigator that the participant should not enter the study due to other conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Renhai Yang

Role: CONTACT

Phone: 021-64311017

Email: [email protected]

Facility Contacts

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The Third Xiangya Hospital of Central South University

Role: primary

Other Identifiers

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PY-HL-1186-AS-Ⅱa-01

Identifier Type: -

Identifier Source: org_study_id