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Clinical Trial Details

Trial ID: L7132
Source ID: NCT05624853
Associated Drug: Pregabalin Sustained Release Tablet
Title: 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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Neuropathic Pain|Diabetes Mellitus, Type 2
Interventions: DRUG: pregabalin sustained release tablet|DRUG: pregabalin immediate release capsule
Outcome Measures: Primary: Change from baseline to week 8 in Visual Analogue Scale(VAS), Baseline/Week 8 | Secondary: Change from baseline to week 8 in Quality of Life(EQ-5D), Baseline/Week 8|Change from baseline to week 8 in Patients Global Impression of Change(PGIC), Baseline/Week 8|Change from baseline to week 8 in Clinician Global Impression of Change(CGIC), Baseline/Week 8|Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS), Baseline/Week 8|Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8), Baseline/Week 8|Dose and frequency of Rescue medication(Acetaminophen), Baseline/Week 8|Number and proportion of subjects with adverse event, Baseline/Week 8
Sponsor/Collaborators: Sponsor: Yuhan Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 130
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-05-12
Completion Date: 2022-12-20
Results First Posted:
Last Update Posted: 2023-10-23
Locations: Chungbuk National University Hospital, Cheongju, Chungcheongbuk-do, 28644, Korea, Republic of|Dankook University Hospital, Cheonan, Chungcheongnam-do, 31116, Korea, Republic of|Catholic University of Korea's Bucheon St. Mary's Hospital, Bucheon, Gyeonggi-do, 14647, Korea, Republic of|Inje University Haeundae Paik Hospital, Busan, 48108, Korea, Republic of|Kosin University Gospel Hospital, Busan, 49267, Korea, Republic of|Chungnam National University Hospital, Daejeon, 35015, Korea, Republic of|Daejeon Eulji Medical Center, Eulji University, Daejeon, 35233, Korea, Republic of|Chungnam National University Sejong Hospital, Sejong, 30099, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05624853

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D062 Pregabalin small molecule DB00230 Details