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This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2129 High Dose Group | Experimental |
| |
| HRS-2129 Low Dose Group | Experimental |
| |
| Pregabalin Group | Active Comparator |
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| Blank Preparation Placebo Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 Tablets | Drug | HRS-2129 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Tang | Contact | +86-0518-82342973 | lei.tang.lt31@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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HRS-2129 compared with placebo.
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| HRS-2129 Placebo | Drug | HRS-2129 placebo. |
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| Pregabalin Capsules | Drug | Pregabalin capsules. |
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| Pregabalin Capsules Placebo | Drug | Pregabalin capsules placebo. |
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| 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. | From Week 1 to Week 4. |
| 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. | 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. | 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). | Baseline and Week 4. |
| Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4. | Patient Global Impression of Change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. | At Week 4. |
| Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4. | The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores. | Baseline and Week 4. |
| Number and severity of serious adverse events (SAEs). | To evaluate the safety of HRS-2129 during the trial. | From Week 1 to Week 6. |
| Number and severity of adverse events (AEs). | To evaluate the safety of HRS-2129 during the trial. | 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. | Population Pharmacokinetics (PopPK) will be determined by measuring serum concentration of HRS-2129. | From Day 0 to Day 30. |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |