The Effect of YJ001 on Diabetic Peripheral Neuropathic Pain.

NCT04953221 | Unknown

• 1 other identifier: D2020155
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change in the average weekly NRS score of pain from the baseline

  1-11 weeks after treatment

• Changes from baseline in the average sleep disturbance scores

  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

  at the 12th week after treatment

Study Arms (6)

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

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

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

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.

Interventions

YJ001 DRUG

Skin spray

M1 Test group; M2 Test group:; M3 Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic peripheral neuropathic pain patients

You may qualify if:

• \- Subjects must meet all of the following criteria to be enrolled in this study.
• The age of screening was 18-75 years old, regardless of gender;
• Diagnosis of type 1 or type 2 diabetes for at least 1 years;
• Diabetic peripheral neuropathic pain was diagnosed and the duration of pain was 23 months.
• The level of glycosylated hemoglobin was less than 9%;
• 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;
• The subjects are willing and able to comply with the study visit arrangement, treatment plan, laboratory examination and other study procedures;
• Those who agree to participate in the trial and sign the written informed consent.

You may not qualify if:

• \- Subjects meeting any one or more of the following criteria will not be allowed to participate in this study.
• 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.
• Those who have participated in yj001 clinical study and received research drugs.
• 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.
• 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.
• 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.
• 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.
• The score of skin condition evaluation of the administration site was more than 2.
• 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.
• Amputation beyond the end of the fingers and toes.
• Diabetic foot ulcers, infection and gangrene were associated with diabetes.
• There are metabolic complications of acute diabetes, such as diabetic ketoacidosis or lactic acidosis or hyperosmolar hyperglycemia syndrome or hyperosmolar diabetic hyperglycemia.
• 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).
• The NRS score of subjects with more than two pain scores was less than 3 points in the 1-week lead-in period.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100098, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)