NCT06780267

Brief Summary

The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 18, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 13, 2025

Last Update Submit

November 14, 2025

Conditions

Postoperative Pain in Orthopaedics

Outcome Measures

Primary Outcomes (1)

  • Safety：Incidence and severity of AE/SAE

    from ICF signing date to day 12 since last dose(14 days)

Secondary Outcomes (9)

  • the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition

    48hours

  • The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication

    48hours

  • Participant ' satisfaction score for analgesia treatment

    48hours

  • Investigator satisfaction score for analgesia treatment

    48hours

  • Time of first use of remedial analgesic medication

    48hours

  • +4 more secondary outcomes

Study Arms (3)

Treatment group: low\middle\high-dose

EXPERIMENTAL

HRS-2129； HRS-2129 placebo

Drug: HRS-2129Drug: HRS-2129 placebo

Treatment group:placebo

EXPERIMENTAL

HRS-2129 placebo

Drug: HRS-2129 placebo

Treatment group: positive control

ACTIVE COMPARATOR

Tramadol Hydrochloride SR Tablets

Drug: Tramadol Hydrochloride SR Tablets

Interventions

HRS-2129DRUG

HRS-2129

Treatment group: low\middle\high-dose
HRS-2129 placeboDRUG

HRS-2129 placebo

Treatment group: low\middle\high-doseTreatment group:placebo
Tramadol Hydrochloride SR TabletsDRUG

Tramadol Hydrochloride SR Tablets

Treatment group: positive control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to provide a written informed consent
  • Subjects requiring elective orthopedic surgery
  • Conform to the ASA Physical Status Classification

You may not qualify if:

  • Subjects with a history of severe allergies
  • Subjects with nervous system disease
  • Subjects with a history of mental illness
  • Subjects with abnormal liver and renal function
  • Subjects with poorly controlled hypertensive or hypotensive
  • QTc：\>450ms（male），\>470ms（female）
  • Subjects who screened positive for substance abuse
  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Central Study Contacts

Lei Tang

CONTACT

+0518-82342973lei.tang.lt31@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

March 11, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-01

Locations

CN(1)