YJ001 Spray for Diabetic Peripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Hanmai Pharmaceutical Technology Co., Ltd.
About this trial
The goal of this clinical trial is to learn if YJ001 Spray works to treat diabetic patients with Diabetic Peripheral Neuropathic Pain..It will also learn about the safety of drug YJ001 Spray.This trial is divided into two parts. The first part of the trial is designed as a randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical trial with positive reference product and placebo; the second part is designed as a single-arm, open-label, multi-center clinical trial.In the first part, the trial was divided into the test group, the positive control group, and the placebo group.
In the first part,The experimental group received YJ001 spray + clobazam besylate capsule placebo, the positive control group received YJ001 spray placebo + clobazam besylate capsule, and the placebo group received YJ001 spray placebo + clobazam besylate capsule placebo. In the second part, all participants were treated with the investigational product, and 30 trial participants underwent PK blood sample collection according to the protocol.
Part I of the trial : To evaluate the efficacy and safety of YJ001 spray in treating diabetic peripheral neuropathic pain.
Part 2 of the trial: Evaluate the long-term efficacy and the pharmacokinetic characteristics of YJ001 spray in treating dia betic peripheral neuropathic pain at the clinically recommended dosage.
Participants will:
Apply spray topically to both feet twice daily, with six sprays per foot at each administration.
Visit the clinic once every 1 or 2 or 4 weeks for checkups and tests Complete a study diary daily to record pain intensity, sleep interference, study-drug administration, and spray-related respiratory irritation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years, of either gender
Diagnosed with type 1 or type 2 diabetes for at least 1 year
Diagnosed with diabetic peripheral neuropathic pain (DPNP, other tertiary hospitals' diagnostic certificates are acceptable), with pain duration ≥6 months, and the most painful area being the foot
Stable blood glucose control within 3 months prior to screening, i.e., glycated hemoglobin (HbA1c) ≤9.0% at screening. If the patient has been receiving hypoglycemic drug treatment at screening, stable treatment for at least 30 days is required;
Disqualifiers
The ADPS score during the run-in period [defined as the average of the daily pain NRS scores calculated based on the patient diary card records excluding the day of randomization] is ≥4, and the trial participant completes at least 10 pain assessments during the run-in period (excluding the day of randomization); - Both pain VAS scores at screening and during the 2-day visit before randomization are ≥40mm and <90mm
Medication adherence to the study drug during the run-in period is 80-120% (inclusive)
The trial participant is willing and able to adhere to study visit schedules, treatment plans, laboratory tests, and other research procedures, agrees to participate in this trial, and signs a written informed consent form.
Trial participants who have completed the double-blind treatment period;
Trial design
Design model
Parallel
Treatments tested in this trial
YJ001 spray simulant
Drugspray：0 mg/dose, once in the morning and once in the evening, 6 sprays per foot each time.
YJ001 spray
Drugspray：480 mg/dose, once in the morning and once in the evening, 6 sprays per foot each time.
Crisugabalin Besilate Capsules
Drugcapsule：20mg per dose, twice a day
Crisugabalin Besilate Capsules simulant
Drug0mg per dose, twice a day
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: Placebo groupPlacebo comparator 2 interventions
Group B: experimental groupExperimental treatment 2 interventions
Group C: positive control groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in Average Daily Pain Score (ADPS)
Change from baseline in Average Daily Pain Score (ADPS). ADPS is collected from patient daily pain diary. The difference between YJ001 spray group and placebo group will be compared.
Time frame
Week 122
Number of participants with clinically significant changes in safety parameters from baseline
Safety parameters including adverse events (AEs), laboratory tests, physical examination, vital signs and electrocardiogram (ECG). Clinically significant changes from baseline will be assessed at Week 52 during the open-label extension part (part two).
Time frame
week 52Secondary outcomes
1
Compared with the placebo group, the Change from baseline in Average Daily Pain Score (ADPS) at weeks 1-11 and 13 after treatment in the test group
ADPS is collected from the average daily pain NRA score based on diary card records. The difference between YJ001 spray group and placebo group will be compared
Time frame
weeks 1-11 and 132
Compared with the positive control group, the change in Average Daily Pain Score（ADPS） from baseline to the 1-13 weeks after treatment in the test group;
ADPS is collected from the average daily pain NRA score based on diary card records.
Time frame
weeks 1-133
The response rates of ADPS (the proportion of trial participants with weekly ADPS decrease of ≥30% and ≥50% relative to baseline) in the three groups at the 12 and 13 week after treatment
Time frame
weeks 12 and 134
The proportion of trial participants with ADPS scores less than 1 in the three groups at the 12 and 13 weeks after treatment
Time frame
12 and 13 weeksSponsors and contacts
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Source ClinicalTrials.gov