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

Phase 2

Recruiting

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: JMKX000623; Drug: Pregabalin; Drug: Placebo

• Registration Number: NCT06221241
• Lead Sponsor: Jemincare

Brief 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

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-24
• Study Start: 2024-03-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-03-14
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JMKX000623	JMKX000623	JMKX000623 for 12 weeks
JMKX000623	Placebo	JMKX000623 for 12 weeks
Pregabalin	Placebo	Pregabalin for 12 weeks
Placebo	Placebo	placebo for 12 weeks
Pregabalin	Pregabalin	Pregabalin for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]	baseline，Week 12	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]

Secondary Outcome Measures

Name	Time	Method
Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]	baseline，Week 5	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
Adverse Events	baseline，Week 12

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China