BridgeMD
New treatment option for Diabetic Peripheral Neuropathic Pain
Official title A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
ClinicalTrials.gov ID: NCT07377721
What this study is testing
What is HRS-2129 Tablets?
HRS-2129 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diabetic peripheral neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able and willing to provide a written informed consent.
- Males or females aged ≥18years of age inclusive.
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
- HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
- At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and \< 90 mm.
You likely can't join if
- people with a history of severe allergies.
- Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic...
- people with abnormal liver and renal function.
- Corrected QT Interval (QTc): \> 450 ms (male), \> 470 ms (female).
- Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral...
- History of suicidal behavior or attempted suicide.
See the full eligibility criteria
- Able and willing to provide a written informed consent.
- Males or females aged ≥18years of age inclusive.
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
- HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
- At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and \< 90 mm.
- people with a history of severe allergies.
- Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
- people with abnormal liver and renal function.
- Corrected QT Interval (QTc): \> 450 ms (male), \> 470 ms (female).
- Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral neuropathic pain (DPNP).
- History of suicidal behavior or attempted suicide.
- Participated in another clinical study within 3 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.