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Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain

A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain

NCT06221241•Jemincare

View on ClinicalTrials.gov

Summary

A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Detailed Description

Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
•2. Age ≥ 18 years, male or female;
•3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
•4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
•5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.

Exclusion Criteria

•1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
•2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
•3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
•4. Known treatment failure on pregabalin or gabapentin;

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 25, 2024

Primary Completion Date

March 14, 2025

Completion Date

April 30, 2025

Last Updated

April 16, 2024

Enrollment

220

ESTIMATED participants

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

JMKX000623

DRUG

Pregabalin

DRUG

Placebo

DRUG

Contacts

Lei Xing, PM

CONTACT

010-66119025 xinglei@jemincare.com

Xiaohui Guo, MD

CONTACT

010-66119025

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain

Inclusion Criteria

Exclusion Criteria

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain

SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.

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Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose