Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin
NCT Number: NCT06490484
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Interventions: DRUG: HSK16149 20mg BID|DRUG: Pregabalin 150mg BID
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-19
Completion Date: 2024-07-14
Locations: The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin

Primary Outcome Measures: Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at week 4., The 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
Secondary Outcome Measures: Compare the change from baseline in Numeric Rating Scales (NRS) between HSK16149 and Pregabalin at week 4., The NRS, in which the participant rates pain on a 11-point numeric rating scale, where 0 = no pain and 10 = worst possible pain., Baseline and week 4|Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at treatment period., The 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 to week 4|Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) betwwen HSK16149 and Pregabalin at week 4., Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:

Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe);

Part 2 - the 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 change from baseline in Daily Sleep Interference Score (DSIS) between HSK16149 and Pregabalin 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 DSIS is based on participants daily sleep interference scores., Baseline and week 4|Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and Pregabalin at week 4., The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The health state index value is a single value on a scale from 0 to 100 scores indicating better health: 0 = indicating worst health and 100 = best imaginable health., Baseline and week 4