Diabetic Peripheral Neuropathic PainPhase 2NCT06490484
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin
A Phase 2 study testing HSK16149 20mg BID and Pregabalin 150mg BID in people with Diabetic Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- HSK16149 20mg BID and Pregabalin 150mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2024to 14 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- 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.
- The investigators determine that there are other conditions that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Chao Zheng, MD, 18857116176, Wallbb_1022@163.com
About this study
Official title: Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study
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
- Being tested
- HSK16149 20mg BID, Pregabalin 150mg BID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149 20mg BIDDrug
Also called Crisugabalin
Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.
Pregabalin 150mg BIDDrug
Also called Pregabalin
Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| HSK16149 20mg BID | Experimental | Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose. Receives: 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. Receives: Drug: Pregabalin 150mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (5)
Compare the change from baseline in Numeric Rating Scales (NRS) between HSK16149 and Pregabalin at week 4.
The NRS, in which the participant rates pain on a 11-point numeric rating scale, where 0 = no pain and 10 = worst possible pain.
Measured: Baseline and week 4
Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at treatment period.
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.
Measured: Baseline to week 4
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) betwwen HSK16149 and Pregabalin at week 4.
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 - 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;
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).
Measured: Baseline and week 4
Compare the change from baseline in Daily Sleep Interference Score (DSIS) between HSK16149 and Pregabalin at week 4.
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 DSIS is based on participants daily sleep interference scores.
Measured: 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.
The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The health state index value is a single value on a scale from 0 to 100 scores indicating better health: 0 = indicating worst health and 100 = best imaginable health.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Apr 2024
- Primary completion12 Jul 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490484
- Sponsor's protocol ID
- HSK16149-207
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study
- ClinicalTrials.gov ID
- NCT06490484
- Acronym / sponsor ID
- HSK16149-207
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 12 Jul 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK16149 20mg BID | Experimental | Drug: HSK16149 20mg BIDDrug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose. |
| Pregabalin 150 BID | Experimental | Drug: Pregabalin 150mg BIDDrug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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:
- History of substance abuse or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK16149 20mg BIDAlso: CrisugabalinDrug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose. | Drug | HSK16149 20mg BID |
| Pregabalin 150mg BIDAlso: PregabalinDrug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose. | Drug | Pregabalin 150 BID |
Primary outcome
Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at week 4.
Time frame: Baseline and 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.
5 secondary outcomes
Compare the change from baseline in Numeric Rating Scales (NRS) between HSK16149 and Pregabalin at week 4.
Time frame: Baseline and week 4
Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at treatment period.
Time frame: Baseline to week 4
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) betwwen HSK16149 and Pregabalin at week 4.
Time frame: Baseline and week 4
Compare the change from baseline in Daily Sleep Interference Score (DSIS) between HSK16149 and Pregabalin at week 4.
Time frame: 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.
Time frame: Baseline and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK16149 20mg BID and Pregabalin 150mg BID in people with Diabetic Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangqiong Li (+8602867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at week 4. (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.