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 October 04, 2024

Recruiting

Keywords

Description

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

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 Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0