Diabetic Peripheral Neuropathic Pain
Conditions
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
Interventions
DRUGJMKX000623
tablets for oral administration.
DRUGPregabalin
capsules for oral administration.
DRUGPlacebo
matched to JMKX000623 and Pregabalin
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactLei Xing, PM
Backup ContactXiaohui Guo, MD
Outcome results
None listed