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Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin

ConditionDiabetic Peripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Neutrophils < 1.5 × 10^9/L, or platelet < 90 × 10^9/L, or hemoglobin < 100 g/L;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK16149 20mg BID

    Drug

    Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.

  • Pregabalin 150mg BID

    Drug

    Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: HSK16149 20mg BIDExperimental treatment 1 intervention
Group B: Pregabalin 150 BIDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and week 4

Secondary outcomes

1

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.

Time frame
Baseline and week 4
2

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.

Time frame
Baseline to week 4
3

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).

Time frame
Baseline and week 4
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.

Time frame
Baseline and week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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