To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Haisco Pharmaceutical Group Co., Ltd.687 enrolled

Overview

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

687

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

HSK16149 20mg BIDDRUG

HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.

HSK16149 40mg BIDDRUG

HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.

HSK16149 60mg BIDDRUG

HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent; 2. Males or females aged 18-75 years of age inclusive; 3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months; 4. HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening; 5. At Screening, pain scale (VAS) of ≥40 mm and \<90 mm. Exclusion Criteria: 1. Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP. 2. Skin conditions in the area affected by neurupathy that could alter sensation. 3. Chronic systemic diseases that may affect subjects' participation in the study. 4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if: 1. Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L, or 2. AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or 3. Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2, or 4. Creatine kinase \> 2.0 × ULN. 5. History of substance abuse or alcohol abuse. 6. Acute complications of diabetes in the 6 months prior to screening. 7. Any active infections at screening. 8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive. 9. Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3). 10. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP. 11. History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds. 12. History of suicidal behavior or attempted suicide. 13. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period. 14. Participated in another clinical study within 30 days prior to screening. 15. Other conditions of the subjects who are unlikely to comply with the protocol. 16. Could potentially affect a subject's safety.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.

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.

Time frame: Baseline and week 5

Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.

Time frame: Baseline and week 13

Secondary Outcomes

Compare the response rate between HSK16149 and placebo at week 5 (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.

Time frame: Baseline and week 5

AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.

Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs.

Time frame: From week 1 to week 5

Compare the response rate between HSK16149 and placebo at week 13 (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.

Central Contacts

Fangqiong Li

CONTACT

+8602867258840 lifangq@haisco.com

Data from ClinicalTrials.gov

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