← Back to all trials
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
Source: ClinicalTrials.gov (NCT05624853). StuddyBuddy aggregates publicly available trial information.