๐ฌIn plain words
What the trial is, and whether it could suit you
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, a
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Aged โฅ18 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 โฅ6 months, and the most painful area being the foot
* Stable blood glucose control within 3 months prior to screening, i.e., glycated hemoglobin (HbA1c) โค9.0% at screening. If the patient has been receiving hypoglycemic drug treatment at screening, stable treatment for at least 30 days is required;
* If the patient has been receiving neurotrophic, circulation-improving, and metabolic drug treatments at screening, stable dosing for at least 30 days is required. If the patient has discontinued neurotrophic, circulation-improving, and metabolic drug treatments at screening, the duration of drug withdrawal must meet at least 7 drug half-lives as determined by the investigator;
* If the patient has been receiving non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.) at screening, stable treatment for at least 12 weeks is required, and the treatment regimen must not be changed during the trial
* If the patient has not been receiving stable non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.), non-pharmacological treatment must be discontinued for at least 1 week prior to screening, and no additional non-pharmacological treatments are planned to be added during the trial
* Pain NRS score โฅ4.0 and \<9.0 at screening
* After the run-in period and before randomization, the trial participant meets all inclusion criteria and does not meet any exclusion criteria
* 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 โฅ4, 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 โฅ40mm 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.
Participants in the second part of the trial must meet all the following criteria to be eligible for enrollment in the second part of this study.
* Trial participants who have completed the double-blind treatment period;
* Trial participants who are willing and capable of adhering to the study visit schedule, treatment plan, laboratory tests, and other research procedures.
Exclusion Criteria:
Experiment Part One
* Known or suspected to be allergic to or have serious adverse reactions to the active ingredients of Kligabalin Benzenesulfonate Capsules or any excipient ingredients, or allergic to or have serious adverse reactions to the ingredients of YJ001 Spray, the ingredients of YJ001 Spray Simulant, paracetamol, aspirin, salicylic acid or similar drugs of YJ001 (such as 5-aminosalicylic acid, sulfasalazine and salicylate);
* Previous use of calcium channel modulators such as pregabalin, gabapentin, krigabalin, and melogabalin without improvement in pain (reported by the patient);
* Those who have participated in the clinical study of YJ001 spray and received the study drug in the past;
* According to the research, the test participants are in the acute stage of diabetes peripheral neuropathic pain, or need surgery for focal compression neuropathy, or have widespread systemic pain that will affect the evaluation of pain at the drug delivery site. According to the judgment of the researchers, the evaluation of pain at the drug delivery site will be affected; Or more severe in the hands or closer areas than in the feet; Or the test participants have pain caused by non diabetes peripheral neuropathy, such as active osteoarthritis, lumbar disc herniation, vitamin B deficiency (vitamin B12, folic acid), alcoholism, herpetic neuralgia, vasculitis, and serious depression, anxiety and other psychological diseases, which will affect the researchers' evaluation of diabetes peripheral neuropathic pain;
* Participants who have severe peripheral vascular disease (such as intermittent claudication and lower limb arterial occlusion) during screening and are deemed unsuitable by the researchers to participate in the trial;
* Abnormal skin conditions at the site of administration can affect the determination of test results, such as:
1. Those with a skin condition evaluation score greater than 2 points at the site of administration;
2. There is skin disease in the affected skin area, which affects the investigator's evaluation of diabetes related peripheral neuropathic pain, or the skin at the administration site is red, swollen, inflamed, damaged or other conditions that affect drug absorption, or according to the investigator's judgment, the test participants have tattoos that may interfere with the research purpose;
3. Patients with foot ulcers, infections and gangrene related to diabetes that have not recovered.
* Malignant tumor patients, except for non metastatic skin basal cell carcinoma or squamous cell carcinoma that has received appropriate treatment or resection, or cervical cancer in situ;
* Amputation of limbs other than the tips of fingers and toes;
* Complicated with acute metabolic complications of diabetes, such as diabetes ketoacidosis or lactic acidosis or hyperosmolar hyperglycemia syndrome or diabetes hyperosmolar coma;
* Within the 6 months prior to screening or during the introduction period, there has been one or more severe hypoglycemic events (referring to trial participants requiring assistance from others