A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain

Yuhan

Status and phase: Completed; Phase 4

Conditions: Neuropathic Pain; Diabetes Mellitus, Type 2

Treatments: Drug: pregabalin sustained release tablet; Drug: pregabalin immediate release capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624853

YMC042

Details and patient eligibility

About

This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.

Enrollment: 130 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 19 years, < 75 years
2. VAS score for diabetic peripheral neuropathy pain ≥ 30
3. Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
4. Type II DM patient and HbA1c ≤ 10 %
5. Written informed consent

Exclusion criteria

1. Patient with hypersensitivity to pregabalin
2. Patient on anti-epileptic drugs
3. Patients with pain caused by other factors than diabetic peripheral neuropathy
4. Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
5. AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
6. Drug-abusing patient
7. Severe depression or uncontrolled abnormal mood and behavioral changes
8. Pregnant and breast-feeding woman
9. Patients who participated in other clinical trials for investigational products within 30 days of screening
10. Patients deemed to be ineligible to participate in the trial by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

pregabalin sustained release tablet

Experimental group

Description:

pregabalin sustained release tablet 150mg qd for 8weeks

Treatment:

Drug: pregabalin sustained release tablet

pregabalin immediate release capsule

Active Comparator group

Description:

pregabalin immediate release capsule 75mg bid for 8weeks

Treatment:

Drug: pregabalin immediate release capsule