Search / Trial NCT06221241

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

Launched by JEMINCARE · Jan 14, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called JMKX000623 to see how well it works and how safe it is for people who have diabetic peripheral neuropathic pain, a type of nerve pain caused by diabetes. The trial is currently looking for participants aged 18 and older who have been experiencing this pain for at least six months and have a specific level of pain measured on a scale. To join the study, participants should be stable on their diabetes medications and not have other painful conditions or allergies to similar medications.

If you decide to participate, you will be randomly assigned to receive either JMKX000623, a placebo (which looks like the medication but has no active ingredients), or another active medication for comparison. Throughout the trial, you will have regular check-ups to monitor your health and pain levels. This research aims to find better treatments for diabetic nerve pain, which could help improve the quality of life for many people living with this condition.

Gender

ALL

Eligibility criteria

  • 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;

About Jemincare

Jemincare is a biopharmaceutical company dedicated to advancing innovative therapies for the treatment of severe diseases with a focus on oncology and autoimmune conditions. With a commitment to research and development, Jemincare leverages cutting-edge science and technology to discover and develop novel drug candidates. The company emphasizes collaboration with leading academic institutions and industry partners to accelerate the translation of scientific discoveries into impactful therapeutic solutions. By prioritizing patient needs and adhering to rigorous clinical standards, Jemincare aims to enhance treatment options and improve the quality of life for patients worldwide.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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