Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin

NCT06490484 | Recruiting Phase 2

• 1 other identifier: HSK16149-207
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compare the change from baseline in Numeric Rating Scales (NRS) between HSK16149 and Pregabalin at week 4.

  Baseline and week 4

• Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at treatment period.

  Baseline to week 4

• Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) betwwen HSK16149 and Pregabalin at week 4.

  Baseline and week 4

• Compare the change from baseline in Daily Sleep Interference Score (DSIS) between HSK16149 and Pregabalin at week 4.

  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.

  Baseline and week 4

Study Arms (2)

HSK16149 20mg BID

EXPERIMENTAL

Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.

Drug: HSK16149 20mg BID

Pregabalin 150 BID

EXPERIMENTAL

Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.

Drug: Pregabalin 150mg BID

Interventions

HSK16149 20mg BID DRUG

Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.

Also known as: Crisugabalin

HSK16149 20mg BID

Pregabalin 150mg BID DRUG

Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.

Also known as: Pregabalin

Pregabalin 150 BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Males or females aged 18-75 years of age inclusive;
• Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
• HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
• Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;
• DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.

You may not qualify if:

• Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
• Skin conditions in the area affected by neurupathy that could alter sensation.
• Chronic systemic diseases that may affect subjects' participation in the study.
• Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:
• Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L;
• AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN;
• Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2;
• Creatine kinase \> 2.0 × ULN.
• History of substance abuse or alcohol abuse.
• Acute complications of diabetes in the 6 months prior to screening.
• Any active infections at screening.
• HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
• Inability or unwillingness to discontinue any other prohibited concomitant medications.
• History of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine or related compounds.
• History of suicidal behavior or attempted suicide.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

BID protein, human; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fangqiong Li

CONTACT

+8602867258840; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 8, 2024
• Study Start: April 19, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 14, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)