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

Jemincare

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Placebo; Drug: Pregabalin; Drug: JMKX000623

Study type: Interventional

Funder types: Industry

Identifiers

NCT06221241

JMKX0623-201

Details and patient eligibility

About

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

Full description

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 3 patient groups, including a placebo group

JMKX000623

Experimental group

Description:

JMKX000623 for 12 weeks

Treatment:

Drug: Placebo

Drug: JMKX000623

Pregabalin

Active Comparator group

Description:

Pregabalin for 12 weeks

Treatment:

Drug: Placebo

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

placebo for 12 weeks

Treatment:

Drug: Placebo