Diabetic Peripheral Neuropathic Pain (DPNP)Phase 2NCT07858344
Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIb Clinical Trial of Spray YJ001 for the Treatment of Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing YJ001 spray simulator, YJ001 Spray 240 mg/day and YJ001 Spray 480 mg/day in people with Diabetic Peripheral Neuropathic Pain (DPNP), run by Zhejiang Yuejia Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if YJ001 Spray can treat diabetic patients with Diabetic Peripheral Neuropathic Pain(DPNP). The main questions it aims to answer are: Is YJ001 spray effective for patients with diabetic peripheral neuropathic pain(DPNP)？ The optimal effective dose of YJ001 spray for patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPNP)
- What is being tested?
- YJ001 spray simulator, YJ001 Spray 240 mg/day and YJ001 Spray 480 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2024to 3 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 to 75 years of age at screening
- The subject is diagnosed with Type 1 or Type 2 diabetes with a disease duration of at least 1 year
- The subject is diagnosed with diabetic peripheral neuropathic pain (DPNP, acceptable diagnostic certificates from other tertiary or higher-level hospitals.). Pain duration ≥ 3 months
- Glycated hemoglobin level (HbA1c) ≤ 9%
- At the screening visits, the score on the 11-point Numerical Rating Scale (NRS) must be ≥4.0. During the 1-week run-in period, subjects must complete at least 15 NRS scores, including 5 scores taken at 6 hours post-dose, and the mean pain score should have been ≥4.0
- Subjects are willing and able to participate in study visits, treatment plans, laboratory tests, and other study procedures
- Consented to participate in this study and signed the written informed consent form (ICF).
Who cannot join
- Subjects who are known or suspected to be allergic to or have had severe adverse reactions to the ingredients of YJ001 , the ingredients of YJ001 placebos for spray use, aspirin, salicylic acid, or YJ001-like drugs (such as 5-aminosalicylic acid, sulfasalazine, and salicylate esters)
- Subjects who participated in the YJ001 clinical study and received the investigational product before
- Subjects had widespread systemic pain that could affect the evaluation of pain at the administration site, as judged by the investigator; or the pain in the hand or more proximal area is more severe than in the foot
- Subjects with severe peripheral vascular disease (such as intermittent claudication) who were deemed by the investigator to be unsuitable for participation in the study at the time of screening
- Subjects have pain caused by non-diabetic peripheral neuropathy, such as active osteoarthritis, stage II or higher peripheral arterial disease, lumbar disc herniation, vitamin B deficiency, alcoholism, herpes neuralgia, vasculitis, and the somatoform pain caused by psychological disorders such as severe depression and anxiety, which may affect the investigator's score for DPNP
- Subjects had autoimmune diseases associated with elevated inflammatory factors at the time of screening, such as rheumatoid arthritis, inflammatory bowel disease, psoriasis, and atopic dermatitis
Show all 24Show fewer
- Presence of a skin disease in the skin area where the drug is administered, in the investigator's judgment, may affect the score for diabetic peripheral neuropathic pain; or the skin at the administration site is redness, inflamed, damaged, or otherwise affected in a way that may interfere with drug absorption; or, in the investigator's judgment, the subject has tattoos or other skin abnormalities that may interfere with the study objectives
- The skin condition of the administration site scored >2
- Malignant tumors, except for non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin that has been appropriately treated or surgically removed, or in situ cervical cancer
- Amputation of any part of the body other than the fingertips or toes
- Combined with diabetes-related foot ulcers, infections, or gangrene
- Acute diabetic metabolic complications, such as diabetic ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic syndrome, or diabetic hyperosmolar coma
- One or more episodes of severe hypoglycemia (defined as requiring assistance from others to obtain carbohydrates, glucagon, or other rescue measures) during the 6 months prior to screening or during the run-in period
- During the one-week run-in period, the subject's NRS pain scores was <3 more than three times
- Subjects who have used transcutaneous electrical nerve stimulation (TENS), acupuncture, or other therapeutic measures within two weeks prior to inclusion, or who require combined transcutaneous electrical nerve stimulation (TENS) or acupuncture treatment during the treatment period
- Use of topical analgesics for the treatment of DPNP (such as capsaicin patches, lidocaine patches, etc.) within 2 weeks prior to inclusion
- Abnormal liver and kidney function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal values, creatinine > 1.5 times the upper limit of normal values
- Combined severe cardiovascular and cerebrovascular diseases (such as second- or third-degree cardiac conduction block, heart failure classified as New York Heart Association （NYHA） Functional Classification III-IV, myocardial infarction, acute stroke, etc.)
- Combined severe respiratory, blood, and hematopoietic system diseases
- Subjects with other neurological disorders (such as cognitive impairment) that the investigator think it might affect the evaluation of diabetic peripheral neuropathic pain or self-assessment, or psychiatric patients who, in the investigator's judgment, are not suitable for participation in this trial
- Subjects with a known or suspected history of alcohol abuse, drug abuse, or dependence within the past year
- Pregnant or lactating women; male subjects (including their female partner) and female subjects of childbearing potential who plan to become pregnant or cannot guarantee the use of one or more contraceptive methods (common contraceptive methods include tubal ligation intrauterine devices, birth control pills, condoms, etc.) from the start of screening until three months after the end of the trial
- Screen subjects who have participated in other clinical trials within the past 3 months
- Other situations where the investigator considers it inappropriate to participate in this trial
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if YJ001 Spray can treat diabetic patients with Diabetic Peripheral Neuropathic Pain(DPNP). The main questions it aims to answer are:
- Is YJ001 spray effective for patients with diabetic peripheral neuropathic pain(DPNP)？
- The optimal effective dose of YJ001 spray for patients with diabetic peripheral neuropathic pain(DPNP).
- Is YJ001 spray safe for patients with diabetic peripheral neuropathic pain(DPNP)？ Researchers will divide YJ001 spray into three different doses of YJ001 spray and compare it with a placebo (a substance that looks similar but does not contain medication) to observe whether YJ001 spray can effectively treat diabetic peripheral neuropathic pain and to determine the optimal effective dose.
Read more
Participants will:
- Apply spray topically to both feet twice daily, with six sprays per foot at each administration.Attend scheduled study visits at baseline and weeks 1, 2, 4, 8, and 12, followed by a visit 1 week after Treatment termination.
- Record their symptoms and the number of times they use the spray.
- Being tested
- YJ001 spray simulator, YJ001 Spray 240 mg/day, YJ001 Spray 480 mg/day, YJ001 Spray 960 mg/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YJ001 spray simulatorDrug
YJ001 spray 0mg/ml，apply spray to both feet 0mg each time,twice daily, with six sprays per foot.
YJ001 Spray 240 mg/dayDrug
YJ001 spray 50mg/ml，apply spray to both feet 120mg each time,twice daily, with six sprays per foot.
YJ001 Spray 480 mg/dayDrug
YJ001 spray 100mg/ml，apply spray to both feet 240mg each time,twice daily, with six sprays per foot.
YJ001 Spray 960 mg/dayDrug
YJ001 spray 200mg/ml，apply spray to both feet 480mg each time,twice daily, with six sprays per foot
| Study group | Role | What they receive |
|---|---|---|
| YJ001 spray simulator | Placebo comparator | Not described Receives: Drug: YJ001 spray simulator |
| YJ001 Spray 240 mg/day | Experimental | Not described Receives: Drug: YJ001 Spray 240 mg/day |
| YJ001 Spray 480 mg/day | Experimental | Not described Receives: Drug: YJ001 Spray 480 mg/day |
| YJ001 Spray 960 mg/day | Experimental | Not described Receives: Drug: YJ001 Spray 960 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weekly average Numeric Rating Scale (NRS) pain score at Week 12 after treatment.
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity
Measured: baseline and week 12
Secondary outcomes (21)
Change from baseline in weekly average NRS pain scores during Week 1-11 after treatment and the follow-up period.
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: baseline and weekly during Weeks 1-11
Change from baseline in weekly average NRS pain scores measured 6 hours after morning dosing during Weeks 1-12 after treatment.
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: baseline and 6 hours after morning dosing during Weeks 1-12
Change from baseline in weekly average NRS pain scores before morning dosing during Week 1-12 after treatment.
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: baseline,before morning dosing during Week 1-12
Change from baseline in weekly average NRS pain scores before evening dosing during Week 1-12 after treatment.
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: baseline,before evening dosing during Week 1-12
Weekly responder rates (≥30 % and ≥50 % reduction) during Week 1-12 after treatment.
Responder is defined as ≥30% or ≥50% reduction in weekly average Numeric Rating Scale (NRS) pain score from baseline. NRS: 0-10, 0=no pain,10=worst imaginable pain, higher scores mean worse pain.
Measured: Weekly during Week 1-12
Change from baseline in weekly average sleep interference scores during Week 1-12 after treatment and the follow-up period.
Weekly average sleep disturbance score. The scale ranges from 0 to 10. Higher scores indicate worse sleep disturbance.
Measured: baseline,Week 1, 2, 4, 8, 12
Change from baseline in Visual Analogue Scale (VAS) pain scores derived from the Short-form McGill Pain Questionnaire（SF-MPQ） at Week 1, 2, 4, 8, 12 after treatment and the follow-up period.
Short-Form McGill Pain Questionnaire Verbal Analogue Scale (SF-MPQ-VAS). The scale ranges from 0 to 10. Higher scores indicate worse pain.
Measured: baseline,Week 1, 2, 4, 8, 12
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 1, 2, 4, 8, 12 after treatment and the follow-up period.
Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 42. Higher scores indicate greater anxiety and depression symptoms.
Measured: baseline,Week 1, 2, 4, 8, 12
Patient's Global Impression of Change (PGIC) at Week 12 after treatment.
Patient Global Impression of Change (PGIC). The scale ranges from 1 to 7. Lower scores indicate better improvement in pain.
Measured: Week 12
Clinician's Global Impression of Change (CGIC) at Week 12 after treatment.
Clinician's Global Impression of Change (CGIC) is a 7-point clinician-rated scale. Scores range from 1 to 7: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Lower scores indicate better clinical improvement.
Measured: Week 12
Change from baseline in 36-Item Short-Form Health Survey (SF-36) scores at Week 12 after treatment.
Short Form-36 (SF-36) quality of life scale. Each domain score ranges from 0 to 100. Higher scores indicate better quality of life.
Measured: baseline and Week 12
Change from baseline in superficial peroneal and sural nerve conduction velocity and action potential amplitude at Week 12 after treatment.
Nerve conduction velocity and compound nerve action potential amplitude of superficial peroneal nerve and sural nerve will be measured by nerve conduction studies. The change from baseline in these electrophysiological parameters will be assessed at Week 12 after treatment. Higher nerve conduction velocity and higher amplitude indicate better nerve function.
Measured: baseline,Week 12
Change from baseline in serum tumour necrosis factor-α (TNF-α) level at Week 12 after treatment.
Serum tumour necrosis factor-α (TNF-α) concentration will be measured in blood samples. The change from baseline in serum TNF-α level will be evaluated at Week 12 after treatment. Lower TNF-α levels indicate reduced inflammatory status (better outcome).
Measured: baseline,Week 12
The self-assessed time for significant pain relief by subjects after treatment (defined as pain NRS score before morning or evening dosing reduction ≥30 % from baseline).
This endpoint measures the self-assessed time to achieve significant pain relief by subjects. Significant pain relief is defined as a ≥30% reduction from baseline in the pre-morning or pre-evening dosing Numeric Rating Scale (NRS) pain score. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain severity. The time to reach this pain relief threshold will be recorded throughout the trial.
Measured: before morning or evening dosing throughout the entire clinical trial period
Changes in NRS pain scores before morning dosing, 1, 3, 6, 9 hours after morning dosing, and before evening dosing within 3 days after significant relief of self-reported pain by the subjects
This endpoint evaluates changes in subject-reported Numeric Rating Scale (NRS) pain scores. Assessments are collected at pre-morning dosing, 1, 3, 6, 9 hours after morning dosing, and pre-evening dosing within 3 days after subjects report significant pain relief. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain severity.
Measured: before morning dosing, 1, 3, 6, 9 hours after morning dosing, and before evening dosing within 3 days after significant relief of self-reported pain by the subjects
Number of participants with clinically significant abnormal laboratory values
Assessment of clinically significant abnormal laboratory values from hematology, serum biochemistry, coagulation and urinalysis tests. Laboratory panel includes hematology (RBC, Hb, WBC, NEU, PLT, NEU%, LYM%), serum biochemistry (AST, ALT, TBIL, GGT, ALP, DBIL, ALB, Scr, eGFR, HbA1c, FPG), coagulation (APTT, PT, TT, FIB, INR), urinalysis (PRO, GLU, LEU, UERY, urine pH).
Measured: Pre-import period,baseline,Week 4, 8, 12
Number of participants with clinically significant abnormal 12/18-lead ECG findings
Assessment of clinically significant abnormal electrocardiogram (ECG) parameters from 12-lead or 18-lead ECG recordings, including heart rate, PR interval, QRS duration, QT interval, QTc interval, and morphological abnormalities.
Measured: Pre-import period,baseline,Week 4, 8, 12
Number of participants with respiratory tract irritation related to spray administration
Incidence of respiratory tract irritation adverse events occurring during spray administration, assessed via clinical inquiry and physical examination at each study visit.
Measured: Week 1,2,4, 8, 12
Any adverse events observed or reported throughout the study period will be documented promptly
Measured: Pre-import period,baseline,Week 1,2, 4, 8, 12
Change from baseline in serum interleukin (IL-6) level at Week 12 after treatment.
Measured: baseline ,Week 12
Change from baseline in serum interleukin IL-1β level at Week 12 after treatment.
Measured: baseline,week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start18 Jan 2024
- Primary completion27 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Yuejia Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858344
- Sponsor's protocol ID
- BOJI2023024YWX
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIb Clinical Trial of Spray YJ001 for the Treatment of Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07858344
- Acronym / sponsor ID
- BOJI2023024YWX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Zhejiang Yuejia Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if YJ001 Spray can treat diabetic patients with Diabetic Peripheral Neuropathic Pain(DPNP). The main questions it aims to answer are:
- Is YJ001 spray effective for patients with diabetic peripheral neuropathic pain(DPNP)？
- The optimal effective dose of YJ001 spray for patients with diabetic peripheral neuropathic pain(DPNP).
- Is YJ001 spray safe for patients with diabetic peripheral neuropathic pain(DPNP)？ Researchers will divide YJ001 spray into three different doses of YJ001 spray and compare it with a placebo (a substance that looks similar but does not contain medication) to observe whether YJ001 spray can effectively treat diabetic peripheral neuropathic pain and to determine the optimal effective dose.
Participants will:
- Apply spray topically to both feet twice daily, with six sprays per foot at each administration.Attend scheduled study visits at baseline and weeks 1, 2, 4, 8, and 12, followed by a visit 1 week after Treatment termination.
- Record their symptoms and the number of times they use the spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YJ001 spray simulator | Placebo comparator | Drug: YJ001 spray simulator |
| YJ001 Spray 240 mg/day | Experimental | Drug: YJ001 Spray 240 mg/day |
| YJ001 Spray 480 mg/day | Experimental | Drug: YJ001 Spray 480 mg/day |
| YJ001 Spray 960 mg/day | Experimental | Drug: YJ001 Spray 960 mg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, between 18 to 75 years of age at screening
- The subject is diagnosed with Type 1 or Type 2 diabetes with a disease duration of at least 1 year
- The subject is diagnosed with diabetic peripheral neuropathic pain (DPNP, acceptable diagnostic certificates from other tertiary or higher-level hospitals.). Pain duration ≥ 3 months
- Glycated hemoglobin level (HbA1c) ≤ 9%
- At the screening visits, the score on the 11-point Numerical Rating Scale (NRS) must be ≥4.0. During the 1-week run-in period, subjects must complete at least 15 NRS scores, including 5 scores taken at 6 hours post-dose, and the mean pain score should have been ≥4.0
Key exclusion criteria (24 listed)
- Subjects who are known or suspected to be allergic to or have had severe adverse reactions to the ingredients of YJ001 , the ingredients of YJ001 placebos for spray use, aspirin, salicylic acid, or YJ001-like drugs (such as 5-aminosalicylic acid, sulfasalazine, and salicylate esters)
- Subjects who participated in the YJ001 clinical study and received the investigational product before
- Subjects had widespread systemic pain that could affect the evaluation of pain at the administration site, as judged by the investigator; or the pain in the hand or more proximal area is more severe than in the foot
- Subjects with severe peripheral vascular disease (such as intermittent claudication) who were deemed by the investigator to be unsuitable for participation in the study at the time of screening
- Subjects have pain caused by non-diabetic peripheral neuropathy, such as active osteoarthritis, stage II or higher peripheral arterial disease, lumbar disc herniation, vitamin B deficiency, alcoholism, herpes neuralgia, vasculitis, and the somatoform pain caused by psychological disorders such as severe depression and anxiety, which may affect the investigator's score for DPNP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YJ001 spray simulatorYJ001 spray 0mg/ml，apply spray to both feet 0mg each time,twice daily, with six sprays per foot. | Drug | YJ001 spray simulator |
| YJ001 Spray 240 mg/dayYJ001 spray 50mg/ml，apply spray to both feet 120mg each time,twice daily, with six sprays per foot. | Drug | YJ001 Spray 240 mg/day |
| YJ001 Spray 480 mg/dayYJ001 spray 100mg/ml，apply spray to both feet 240mg each time,twice daily, with six sprays per foot. | Drug | YJ001 Spray 480 mg/day |
| YJ001 Spray 960 mg/dayYJ001 spray 200mg/ml，apply spray to both feet 480mg each time,twice daily, with six sprays per foot | Drug | YJ001 Spray 960 mg/day |
Primary outcome
Change from baseline in weekly average Numeric Rating Scale (NRS) pain score at Week 12 after treatment.
Time frame: baseline and week 12
Numeric Rating Scale (NRS). This scale ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain. Higher scores indicate worse pain severity
21 secondary outcomes
Change from baseline in weekly average NRS pain scores during Week 1-11 after treatment and the follow-up period.
Time frame: baseline and weekly during Weeks 1-11
Change from baseline in weekly average NRS pain scores measured 6 hours after morning dosing during Weeks 1-12 after treatment.
Time frame: baseline and 6 hours after morning dosing during Weeks 1-12
Change from baseline in weekly average NRS pain scores before morning dosing during Week 1-12 after treatment.
Time frame: baseline,before morning dosing during Week 1-12
Change from baseline in weekly average NRS pain scores before evening dosing during Week 1-12 after treatment.
Time frame: baseline,before evening dosing during Week 1-12
Weekly responder rates (≥30 % and ≥50 % reduction) during Week 1-12 after treatment.
Time frame: Weekly during Week 1-12
Change from baseline in weekly average sleep interference scores during Week 1-12 after treatment and the follow-up period.
Time frame: baseline,Week 1, 2, 4, 8, 12
Change from baseline in Visual Analogue Scale (VAS) pain scores derived from the Short-form McGill Pain Questionnaire（SF-MPQ） at Week 1, 2, 4, 8, 12 after treatment and the follow-up period.
Time frame: baseline,Week 1, 2, 4, 8, 12
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 1, 2, 4, 8, 12 after treatment and the follow-up period.
Time frame: baseline,Week 1, 2, 4, 8, 12
Patient's Global Impression of Change (PGIC) at Week 12 after treatment.
Time frame: Week 12
Clinician's Global Impression of Change (CGIC) at Week 12 after treatment.
Time frame: Week 12
Change from baseline in 36-Item Short-Form Health Survey (SF-36) scores at Week 12 after treatment.
Time frame: baseline and Week 12
Change from baseline in superficial peroneal and sural nerve conduction velocity and action potential amplitude at Week 12 after treatment.
Time frame: baseline,Week 12
Change from baseline in serum tumour necrosis factor-α (TNF-α) level at Week 12 after treatment.
Time frame: baseline,Week 12
The self-assessed time for significant pain relief by subjects after treatment (defined as pain NRS score before morning or evening dosing reduction ≥30 % from baseline).
Time frame: before morning or evening dosing throughout the entire clinical trial period
Changes in NRS pain scores before morning dosing, 1, 3, 6, 9 hours after morning dosing, and before evening dosing within 3 days after significant relief of self-reported pain by the subjects
Time frame: before morning dosing, 1, 3, 6, 9 hours after morning dosing, and before evening dosing within 3 days after significant relief of self-reported pain by the subjects
Number of participants with clinically significant abnormal laboratory values
Time frame: Pre-import period,baseline,Week 4, 8, 12
Number of participants with clinically significant abnormal 12/18-lead ECG findings
Time frame: Pre-import period,baseline,Week 4, 8, 12
Number of participants with respiratory tract irritation related to spray administration
Time frame: Week 1,2,4, 8, 12
Any adverse events observed or reported throughout the study period will be documented promptly
Time frame: Pre-import period,baseline,Week 1,2, 4, 8, 12
Change from baseline in serum interleukin (IL-6) level at Week 12 after treatment.
Time frame: baseline ,Week 12
Change from baseline in serum interleukin IL-1β level at Week 12 after treatment.
Time frame: baseline,week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YJ001 spray simulator, YJ001 Spray 240 mg/day and YJ001 Spray 480 mg/day in people with Diabetic Peripheral Neuropathic Pain (DPNP), run by Zhejiang Yuejia Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weekly average Numeric Rating Scale (NRS) pain score at Week 12 after treatment. (time frame: baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.