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
Overview
- Phase
- Phase 2
- Intervention
- JMKX000623
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Sponsor
- Jemincare
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- 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)]
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand the procedures of this trial and provide written informed consent voluntarily;
- •Age ≥ 18 years, male or female;
- •Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
- •Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
- •HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.
Exclusion Criteria
- •With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
- •Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
- •Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
- •Known treatment failure on pregabalin or gabapentin;
Arms & Interventions
JMKX000623
JMKX000623 for 12 weeks
Intervention: JMKX000623
JMKX000623
JMKX000623 for 12 weeks
Intervention: Placebo
Pregabalin
Pregabalin for 12 weeks
Intervention: Pregabalin
Pregabalin
Pregabalin for 12 weeks
Intervention: Placebo
Placebo
placebo for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
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)]
Time Frame: baseline，Week 12
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
Secondary Outcomes
- 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)
- Adverse Events(baseline，Week 12)