Back to resultsTo Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Primary Purpose
Diabetic Peripheral Neuropathic Pain
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK16149 20mg BID
HSK16149 40mg BID
HSK16149 60mg BID
HSK16149 80mg BID
Pregabalin 150mg BID
Placebo BID
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- 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 ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
- At Screening, pain scale (VAS) of ≥40 mm and <90 mm.
Exclusion Criteria:
- 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, or
- AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or
- Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2, or
- 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 (see Section 6.3).
- Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
- History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds.
- History of suicidal behavior or attempted suicide.
- 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.
- Participated in another clinical study within 30 days prior to screening.
- Other conditions of the subjects who are unlikely to comply with the protocol.
- Could potentially affect a subject's safety.
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
HSK16149 20mg BID
HSK16149 40mg BID
HSK16149 60mg BID
HSK16149 80mg BID
Pregabalin 150mg BID
Placebo BID
Arm Description
Outcomes
Primary Outcome Measures
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.
Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
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.
Secondary Outcome Measures
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.
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.
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.
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.
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.
Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.
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.
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.
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 - a visual analog scale (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)
Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.
Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse.
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.
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 ADSIS is based on participants daily sleep interference scores.
Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.
The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire.
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs.
Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.
Pharmacokinetics will be determined by measuring serum concentration of HSK16149.
Full Information
NCT ID
NCT04647773
First Posted
November 16, 2020
Last Updated
November 30, 2020
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04647773
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2020 (Anticipated)
Primary Completion Date
November 9, 2022 (Anticipated)
Study Completion Date
November 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
687 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HSK16149 20mg BID
Arm Type
Experimental
Arm Title
HSK16149 40mg BID
Arm Type
Experimental
Arm Title
HSK16149 60mg BID
Arm Type
Experimental
Arm Title
HSK16149 80mg BID
Arm Type
Experimental
Arm Title
Pregabalin 150mg BID
Arm Type
Active Comparator
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HSK16149 20mg BID
Intervention Description
HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
HSK16149 40mg BID
Intervention Description
HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
HSK16149 60mg BID
Intervention Description
HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
HSK16149 80mg BID
Intervention Description
HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg BID
Intervention Description
Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
Placebo BID
Intervention Description
Placebo, orally twice a day, treatment period; 13-weeks fixed dose.
Primary Outcome Measure Information:
Title
Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
Description
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
Title
Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
Description
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 13
Secondary Outcome Measure Information:
Title
Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Description
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
Title
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.
Description
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
Title
Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Description
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 13
Title
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.
Description
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
From week 1 to week 13
Title
Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.
Description
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.
Time Frame
Baseline and week 13
Title
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.
Description
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 - a visual analog scale (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)
Time Frame
Baseline and week 13
Title
Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.
Description
Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse.
Time Frame
Week 13
Title
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.
Description
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 ADSIS is based on participants daily sleep interference scores.
Time Frame
Baseline and week 13
Title
Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.
Description
The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire.
Time Frame
Baseline and week 13
Title
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.
Description
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs.
Time Frame
From week 1 to week 14
Title
Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.
Description
Pharmacokinetics will be determined by measuring serum concentration of HSK16149.
Time Frame
Week 1,week 5,week 11,week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
At Screening, pain scale (VAS) of ≥40 mm and <90 mm.
Exclusion Criteria:
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, or
AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or
Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2, or
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 (see Section 6.3).
Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds.
History of suicidal behavior or attempted suicide.
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.
Participated in another clinical study within 30 days prior to screening.
Other conditions of the subjects who are unlikely to comply with the protocol.
Could potentially affect a subject's safety.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangqiong Li
Phone
+8602867258840
Email
lifangq@haisco.com
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Guo, M.D.
Phone
13601337277
Email
guoxh@medmail.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
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