Recruiting NCT07377721
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-2129 Tablets, HRS-2129 Placebo, Pregabalin Capsules, Pregabalin Capsules Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Overview
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
Interventions
- Drug HRS-2129 Tablets
HRS-2129 tablets. - Drug HRS-2129 Placebo
HRS-2129 placebo. - Drug Pregabalin Capsules
Pregabalin capsules. - Drug Pregabalin Capsules Placebo
Pregabalin capsules placebo.
Primary outcome measures
- Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4. [Time frame: Baseline and Week 4.]
Secondary outcome measures (9)
- Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline). [Time frame: Baseline and Week 4.]
- Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4. [Time frame: From Week 1 to Week 4.]
- Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4. [Time frame: Baseline and Week 4.]
- Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HRS-2129 and placebo at Week 4. [Time frame: Baseline and Week 4.]
- Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4. [Time frame: At Week 4.]
- Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4. [Time frame: Baseline and Week 4.]
- Number and severity of serious adverse events (SAEs). [Time frame: From Week 1 to Week 6.]
- Number and severity of adverse events (AEs). [Time frame: From Week 1 to Week 6.]
- Population Pharmacokinetics (PopPK) characteristics of HRS-2129 in Chinese patients with diabetic peripheral neuropathic pain - Serum concentration of HRS-2129. [Time frame: From Day 0 to Day 30.]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- Subjects 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).
- Subjects 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- China-Japan Friendship Hospital — Beijing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
Identifiers
NCT: NCT07377721 · HRS-2129-105