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 | Completed Phase 4

• 1 other identifier: YMC042
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

pregabalin sustained release tablet

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 8 in Visual Analogue Scale(VAS)

  Baseline/Week 8

Secondary Outcomes (7)

• 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

Study Arms (2)

pregabalin sustained release tablet

EXPERIMENTAL

pregabalin sustained release tablet 150mg qd for 8weeks

Drug: pregabalin sustained release tablet

pregabalin immediate release capsule

ACTIVE COMPARATOR

pregabalin immediate release capsule 75mg bid for 8weeks

Drug: pregabalin immediate release capsule

Interventions

pregabalin sustained release tablet DRUG

pregabalin sustained release tablet 150mg qd for 8weeks

pregabalin sustained release tablet

pregabalin immediate release capsule DRUG

pregabalin immediate release capsule 75mg bid for 8weeks

pregabalin immediate release capsule

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 19 years, \< 75 years
• VAS score for diabetic peripheral neuropathy pain ≥ 30
• Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
• Type II DM patient and HbA1c ≤ 10 %
• Written informed consent

You may not qualify if:

• Patient with hypersensitivity to pregabalin
• Patient on anti-epileptic drugs
• Patients with pain caused by other factors than diabetic peripheral neuropathy
• Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
• AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
• Drug-abusing patient
• Severe depression or uncontrolled abnormal mood and behavioral changes
• Pregnant and breast-feeding woman
• Patients who participated in other clinical trials for investigational products within 30 days of screening
• Patients deemed to be ineligible to participate in the trial by investigator

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (8)

Dankook University Hospital

Cheonan, Chungcheongnam-do, 31116, South Korea

Location

Catholic University of Korea's Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Daejeon Eulji Medical Center, Eulji University

Daejeon, 35233, South Korea

Location

Chungnam National University Sejong Hospital

Sejong, 30099, South Korea

Location

Related Publications (1)

• Joung KH, Kim TN, Ku EJ, Lee SS, Yoo WS, Park KS, Kwon SK, Ku BJ. A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain. J Diabetes Complications. 2024 Aug;38(8):108809. doi: 10.1016/j.jdiacomp.2024.108809. Epub 2024 Jul 14.

  PMID: 39018898 DERIVED

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus, Type 2

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bon Jeong Ku

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: May 12, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)