To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT04647773
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
687 participants
INTERVENTIONAL
2020-12-02
2022-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HSK16149 20mg BID
HSK16149 20mg BID
HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.
HSK16149 40mg BID
HSK16149 40mg BID
HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
HSK16149 60mg BID
HSK16149 60mg BID
HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
HSK16149 80mg BID
HSK16149 80mg BID
HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Pregabalin 150mg BID
Pregabalin 150mg BID
Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Placebo BID
Placebo BID
Placebo, orally twice a day, treatment period; 13-weeks fixed dose.
Interventions
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HSK16149 20mg BID
HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.
HSK16149 40mg BID
HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
HSK16149 60mg BID
HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
HSK16149 80mg BID
HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Pregabalin 150mg BID
Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Placebo BID
Placebo, orally twice a day, treatment period; 13-weeks fixed dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaohui Guo, M.D.
Role: primary
References
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Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.
Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.
Other Identifiers
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HSK16149-201/301
Identifier Type: -
Identifier Source: org_study_id