This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
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.
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).
Parallel
HRS-2129 Tablets
DrugHRS-2129 tablets.
HRS-2129 Placebo
DrugHRS-2129 placebo.
Pregabalin Capsules
DrugPregabalin capsules.
Pregabalin Capsules Placebo
DrugPregabalin capsules placebo.
Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4.
The mean change in Average Daily Pain Score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]). The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline).
Ratio of participants responding to treatment, as measured by Average Daily Pain Score (ADPS) reduction from baseline. The ADPS is used to determine categorical response rates.
Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4.
The mean change in Average Daily Pain Score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]). The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4.
VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HRS-2129 and placebo at Week 4.
Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score: Part 1 - 11 descriptors of pain intensity, and 4 descriptors of emotions, on a scale of 0 (none) to 3 (severe); Part 2 - a Visual Analog Scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain; Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain).
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