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Active Not Recruiting NCT05624853

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

Conditions: Neuropathic Pain, Diabetes Mellitus, Type 2

Sex: All
Ages: 19 Years – 74 Years
Phase: PHASE4
Enrollment: 130
Sponsor: Yuhan Corporation

Location: Korea, Republic of

Summary

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.

Eligibility Criteria

Inclusion Criteria:Aged ≥ 19 years, < 75 yearsVAS score for diabetic peripheral neuropathy pain ≥ 30Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeksType II DM patient and HbA1c ≤ 10 %Written informed consentExclusion Criteria:Patient with hypersensitivity to pregabalinPatient on anti-epileptic drugsPatients with pain caused by other factors than diabetic peripheral neuropathyPatients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screeningAST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver diseaseDrug-abusing patientSevere depression or uncontrolled abnormal mood and behavioral changesPregnant and breast-feeding womanPatients who participated in other clinical trials for investigational products within 30 days of screeningPatients deemed to be ineligible to participate in the trial by investigator

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05624853). StuddyBuddy aggregates publicly available trial information.