The Effect of YJ001 on Diabetic Peripheral Neuropathic Pain.
NCT ID: NCT04953221
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
225 participants
OBSERVATIONAL
2021-07-01
2023-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
NCT06361108
Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
NCT06221241
Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain
NCT07159243
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT04094662
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
NCT00993018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
No interventions assigned to this group
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.
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.
No interventions assigned to this group
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YJ001
Skin spray
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D2020155
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.