The Effect of YJ001 on Diabetic Peripheral Neuropathic Pain.

A Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Effectiveness and Safety of Spray YJ001 in the Treatment of Diabetic Peripheral Neuropathic Pain.

In this study, a randomized, double-blind, placebo parallel-controlled design was used to evaluate the effectiveness and safety of YJ001 spray applied to local skin in patients with diabetic peripheral neuropathic pain, and to explore the best effective dose.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: YJ001

Detailed Description

In this study, a randomized, double-blind, placebo parallel-controlled design was used to evaluate the effectiveness and safety of YJ001 spray applied to local skin in patients with diabetic peripheral neuropathic pain, and to explore the best effective dose.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100098
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic peripheral neuropathic pain patients

Description

Inclusion Criteria:

- Subjects must meet all of the following criteria to be enrolled in this study.

1. The age of screening was 18-75 years old, regardless of gender;
2. Diagnosis of type 1 or type 2 diabetes for at least 1 years;
3. Diabetic peripheral neuropathic pain was diagnosed and the duration of pain was 23 months.
4. The level of glycosylated hemoglobin was less than 9%;
5. At the screening visit, according to the 11 point digital pain intensity scale (NRS), the score was greater than or equal to 4; During the 1-week lead-in period, subjects completed at least 10 NRS pain scores, and the average pain score was greater than or equal to 4.0;
6. The subjects are willing and able to comply with the study visit arrangement, treatment plan, laboratory examination and other study procedures;
7. Those who agree to participate in the trial and sign the written informed consent.

Exclusion Criteria:

- Subjects meeting any one or more of the following criteria will not be allowed to participate in this study.

1. Have known or suspected the ingredients of spray YJ001, the ingredients of YJ001 simulant, and ASA.

   Those who are allergic to aspirin, salicylic acid or yj001 (such as 5-aminosalicylic acid, sulfasalazine and salicylate) or have serious adverse reactions.

2. Those who have participated in yj001 clinical study and received research drugs.
3. The subjects have a wide range of systemic pain, which will affect the pain evaluation of the drug delivery site according to the judgment of the researchers; Or in the hand or more proximal area than the foot.
4. The subjects with severe peripheral vascular disease (such as intermittent claudication) at the time of screening were not suitable for the trial according to the judgment of the researchers.
5. Subjects suffered from nondiabetic peripheral neuropathy, such as osteoarthritis, II stage and above peripheral arterial disease, lumbar disc herniation, vitamin B deficiency, alcoholism, herpes neuralgia, vasculitis, and severe mental disorders such as depression and anxiety. It will also affect the researchers' evaluation of diabetic peripheral neuropathic pain.
6. There is skin disease in the affected skin area. According to the judgement of the researcher, it may affect the evaluation of diabetic peripheral neuropathic pain. According to the judgment of the researcher, the subjects have tattoos or other skin abnormalities that may interfere with the purpose of the study.
7. The score of skin condition evaluation of the administration site was more than 2.
8. Patients with malignant tumors, but have received appropriate treatment or resection of non metastatic skin basal cell carcinoma or squamous cell carcinoma, or cervical cancer in situ.
9. Amputation beyond the end of the fingers and toes.
10. Diabetic foot ulcers, infection and gangrene were associated with diabetes.
11. There are metabolic complications of acute diabetes, such as diabetic ketoacidosis or lactic acidosis or hyperosmolar hyperglycemia syndrome or hyperosmolar diabetic hyperglycemia.
12. One or more severe hypoglycemia events occurred 6 months before screening or during the induction period (it means that the subjects need help from others to obtain carbohydrates, glucagon or other rescue measures).
13. The NRS score of subjects with more than two pain scores was less than 3 points in the 1-week lead-in period.
14. Patients who had used transcutaneous electrical nerve stimulation (TENS), acupuncture and other treatment measures within 2 weeks before entering the group, or during the treatment period, subjects need combined transcutaneous electrical nerve stimulation (TENS) or acupuncture treatment.
15. Local analgesics (such as capsaicin patches and lidocaine patches) used in the treatment of diabetic peripheral neuropathic pain in the first 2 weeks.
16. Abnormal liver and kidney function: ast or aut > 2.5 times the upper limit of normal value, creatinine > 1.5 times the upper limit of normal value.
17. Complicated with severe cardiovascular and cerebrovascular diseases (such as degree II or III heart block, congestive heart failure with NYHA cardiac function grade III-IV, myocardial infarction, and acute stroke).
18. Severe diseases of respiratory system, blood and hematopoietic system were found.
19. There are other neurological diseases (such as cognitive impairment). The researchers believe that it may affect the evaluation of diabetic peripheral neuropathic pain or affect self ratings, or the psychiatric patients who are not suitable for the trial by the researchers.
20. Patients with known or suspected history of alcohol abuse, drug abuse or dependence in the past year.
21. Pregnant and lactating women; The male subjects (including their female partners) and the fertile female subjects had the intention of having children or could not guarantee the use of one or more contraceptives within 3 months from the beginning of screening to the end of the trial.
22. Those who participated in other clinical trials within 3 months before screening.
23. Other cases that the researcher considered unsuitable to participate in this trial.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
M1 Test group; YJ001 for spray, topical application on the skin, drug concentration 100mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.	Drug: YJ001; Skin spray
M1 control group; YJ001 simulant for spray, topical application on the skin, drug concentration 100mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.
M2 Test group: YJ001 for spray, topical application on the skin, drug concentration 150mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.	Drug: YJ001; Skin spray
M2 control group: YJ001 simulant for spray, topical application on the skin, drug concentration 150mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.
M3 Test group; YJ001 for spray, topical application on the skin, drug concentration 200mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.	Drug: YJ001; Skin spray
M3 control group; YJ001 simulant for spray, topical application on the skin, drug concentration 200mg/mL, 2 times/day (interval 11-13h), 8 sprays each time, a total of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the average weekly NRS score of pain from baseline	Numerical Rating Scale ：0-10 points, the greater the score, the more severe the pain.	at the twelfth week after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the average weekly NRS score of pain from the baseline	Numerical Rating Scale ：0-10 points, the greater the score, the more severe the pain.	1-11 weeks after treatment
Changes from baseline in the average sleep disturbance scores	sleep disturbance scores：0-10 points, the greater the score, the more severe the sleep disturbance.	each week and during the follow-up period from 1 to 12 weeks after treatment
The change from baseline in the SF-36 Quality of Life Scale score	SF-36 Quality of Life Scale score：0-100 points, the smaller the score, the more severe the quality of life.	at the 12th week after treatment

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies
• Other Study ID Numbers: D2020155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No