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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Neuropathic Pain
• Intervention / Treatment: Drug: pregabalin sustained release tablet; Drug: pregabalin immediate release capsule

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of, 35233
    • Daejeon Eulji Medical Center, Eulji University
  • Sejong, Korea, Republic of, 30099
    • Chungnam National University Sejong Hospital
  • Chungcheongbuk-do
    • Cheongju, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 31116
      • Dankook University Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14647
      • Catholic University of Korea's Bucheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pregabalin sustained release tablet; pregabalin sustained release tablet 150mg qd for 8weeks	Drug: pregabalin sustained release tablet; pregabalin sustained release tablet 150mg qd for 8weeks
Active Comparator: pregabalin immediate release capsule; pregabalin immediate release capsule 75mg bid for 8weeks	Drug: pregabalin immediate release capsule; pregabalin immediate release capsule 75mg bid for 8weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 8 in Visual Analogue Scale(VAS)	Baseline/Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Bon Jeong Ku, Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pregabalin sustained release tablet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus, Type 2; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: YMC042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No