Clinical trial NCT04647773: To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 687
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
timeFrame: Baseline and week 5
measure: Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
timeFrame: Baseline and week 13
Secondary outcomes:
measure: Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
timeFrame: Baseline and week 5
measure: AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.
timeFrame: From week 1 to week 5
measure: Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
timeFrame: Baseline and week 13
measure: Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.
timeFrame: From week 1 to week 13
measure: Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.
timeFrame: Baseline and week 13
measure: Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.
timeFrame: Baseline and week 13
measure: Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.
timeFrame: Week 13
measure: Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.
timeFrame: Baseline and week 13
measure: Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.
timeFrame: Baseline and week 13
measure: AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.
timeFrame: From week 1 to week 14
measure: Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.
timeFrame: Week 1,week 5,week 11,week 13
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: