Diabetic Peripheral Neuropathic PainNCT04953221
The Effect of YJ001 on Diabetic Peripheral Neuropathic Pain.
An observational study of Diabetic Peripheral Neuropathic Pain, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- YJ001
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2023
- Phase
- Observational
- 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
Study population: Diabetic peripheral neuropathic pain patients
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Local analgesics (such as capsaicin patches and lidocaine patches) used in the treatment of diabetic peripheral neuropathic pain in the first 2 weeks.
- 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.
- 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).
- Severe diseases of respiratory system, blood and hematopoietic system were found.
- 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.
- Patients with known or suspected history of alcohol abuse, drug abuse or dependence in the past year.
- 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.
- Those who participated in other clinical trials within 3 months before screening.
- Other cases that the researcher considered unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100098
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- YJ001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YJ001Drug
Skin spray
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the twelfth week after treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at the 12th week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953221
- Sponsor's protocol ID
- D2020155
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04953221
- Acronym / sponsor ID
- D2020155
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 7 Jul 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| M1 Test group | – | Drug: YJ001YJ001 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. |
| 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: | – | Drug: YJ001YJ001 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. |
| 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 | – | Drug: YJ001YJ001 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic peripheral neuropathic pain patients
Key inclusion criteria (8 listed)
- 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%;
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| YJ001Skin spray | Drug | M1 Test group, M2 Test group:, M3 Test group |
Primary outcome
The change in the average weekly NRS score of pain from baseline
Time frame: at the twelfth week after treatment
Numerical Rating Scale ：0-10 points, the greater the score, the more severe the pain.
3 secondary outcomes
The change in the average weekly NRS score of pain from the baseline
Time frame: 1-11 weeks after treatment
Changes from baseline in the average sleep disturbance scores
Time frame: 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
Time frame: at the 12th week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Diabetic Peripheral Neuropathic Pain, run by Peking University Third Hospital 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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
The change in the average weekly NRS score of pain from baseline (time frame: at the twelfth week after treatment). 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 7 Jul 2021.