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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

NCT05624853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain
  • Diabetes Mellitus, Type 2

Interventions

DRUG

pregabalin sustained release tablet

pregabalin sustained release tablet 150mg qd for 8weeks

DRUG

pregabalin immediate release capsule

pregabalin immediate release capsule 75mg bid for 8weeks

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Bon Jeong Ku · Chungnam National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05624853 on ClinicalTrials.gov