Diabetic Peripheral Neuropathic PainPhase 2NCT06221241
Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing JMKX000623 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Jemincare at 1 site in China.
Trial summary
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- JMKX000623 and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the procedures of this trial and provide written informed consent voluntarily;
- Age ≥ 18 years, male or female;
- Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
- Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
- HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.
Who cannot join
- With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
- Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
- Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
- Known treatment failure on pregabalin or gabapentin;
Trial locations and contacts
1 site in 1 country.
Xiaohui Guo, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Lei Xing, PM, 010-66119025, xinglei@jemincare.com
Xiaohui Guo, MD, 010-66119025, xinglei@jemincare.com
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
Read the detailed description
Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- JMKX000623, Pregabalin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000623Drug
tablets for oral administration.
PregabalinDrug
capsules for oral administration.
PlaceboDrug
matched to JMKX000623 and Pregabalin
| Study group | Role | What they receive |
|---|---|---|
| JMKX000623 | Experimental | JMKX000623 for 12 weeks Receives: Drug: JMKX000623; Drug: Placebo |
| Pregabalin | Active comparator | Pregabalin for 12 weeks Receives: Drug: Pregabalin; Drug: Placebo |
| Placebo | Placebo comparator | placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
Measured: baseline，Week 12
Secondary outcomes (2)
Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
Measured: baseline，Week 5
Adverse Events
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 posted24 Jan 2024
- Study start25 Mar 2024
- Primary completion14 Mar 2025 (estimated)
- Study completion30 Apr 2025 (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 JemincareThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221241
- Sponsor's protocol ID
- JMKX0623-201
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT06221241
- Acronym / sponsor ID
- JMKX0623-201
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
Detailed description
Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMKX000623 | Experimental | Drug: JMKX000623, Drug: PlaceboJMKX000623 for 12 weeks |
| Pregabalin | Active comparator | Drug: Pregabalin, Drug: PlaceboPregabalin for 12 weeks |
| Placebo | Placebo comparator | Drug: Placeboplacebo for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand the procedures of this trial and provide written informed consent voluntarily;
- Age ≥ 18 years, male or female;
- Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
- Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
- HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.
Key exclusion criteria (4 listed)
- With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
- Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
- Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
- Known treatment failure on pregabalin or gabapentin;
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 |
|---|---|---|
| JMKX000623tablets for oral administration. | Drug | JMKX000623 |
| Pregabalincapsules for oral administration. | Drug | Pregabalin |
| Placebomatched to JMKX000623 and Pregabalin | Drug | JMKX000623, Placebo, Pregabalin |
Primary outcome
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
Time frame: baseline，Week 12
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
2 secondary outcomes
Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
Time frame: baseline，Week 5
Adverse Events
Time frame: baseline，Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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.
Xiaohui Guo, MD contact
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 JMKX000623 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Jemincare 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 5 inclusion and 4 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 16 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Xing, PM (010-66119025, xinglei@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)] (time frame: baseline，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 16 Apr 2024.