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

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221241
• Other study ID #: JMKX0623-201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Jemincare
• Contact: Lei Xing, PM
• Phone: 010-66119025
• Email: xinglei[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 30, 2025
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• JMKX000623
tablets for oral administration.
• Pregabalin
capsules for oral administration.
• Placebo
matched to JMKX000623 and Pregabalin

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)]	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]	baseline,Week 12
Secondary	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)]	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]	baseline,Week 5
Secondary	Adverse Events		baseline,Week 12