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

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

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2025-04-30

Brief Summary

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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

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Detailed Description

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

Conditions

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Diabetic Peripheral Neuropathic 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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JMKX000623

JMKX000623 for 12 weeks

Group Type EXPERIMENTAL

JMKX000623

Intervention Type DRUG

tablets for oral administration.

Placebo

Intervention Type DRUG

matched to JMKX000623 and Pregabalin

Pregabalin

Pregabalin for 12 weeks

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

capsules for oral administration.

Placebo

Intervention Type DRUG

matched to JMKX000623 and Pregabalin

Placebo

placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matched to JMKX000623 and Pregabalin

Interventions

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JMKX000623

tablets for oral administration.

Intervention Type DRUG

Pregabalin

capsules for oral administration.

Intervention Type DRUG

Placebo

matched to JMKX000623 and Pregabalin

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No