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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

Primary Purpose

Neuropathic Pain, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pregabalin sustained release tablet
pregabalin immediate release capsule
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring pregabalin sustained release tablet

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Chungbuk National University Hospital
  • Dankook University Hospital
  • Catholic University of Korea's Bucheon St. Mary's Hospital
  • Inje University Haeundae Paik Hospital
  • Kosin University Gospel Hospital
  • Chungnam National University Hospital
  • Daejeon Eulji Medical Center, Eulji University
  • Chungnam National University Sejong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pregabalin sustained release tablet

pregabalin immediate release capsule

Arm Description

pregabalin sustained release tablet 150mg qd for 8weeks

pregabalin immediate release capsule 75mg bid for 8weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline to week 8 in Quality of Life(EQ-5D)
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
Dose and frequency of Rescue medication(Acetaminophen)
Number and proportion of subjects with adverse event

Full Information

First Posted
November 14, 2022
Last Updated
October 18, 2023
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05624853
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Diabetes Mellitus, Type 2
Keywords
pregabalin sustained release tablet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin sustained release tablet
Arm Type
Experimental
Arm Description
pregabalin sustained release tablet 150mg qd for 8weeks
Arm Title
pregabalin immediate release capsule
Arm Type
Active Comparator
Arm Description
pregabalin immediate release capsule 75mg bid for 8weeks
Intervention Type
Drug
Intervention Name(s)
pregabalin sustained release tablet
Intervention Description
pregabalin sustained release tablet 150mg qd for 8weeks
Intervention Type
Drug
Intervention Name(s)
pregabalin immediate release capsule
Intervention Description
pregabalin immediate release capsule 75mg bid for 8weeks
Primary Outcome Measure Information:
Title
Change from baseline to week 8 in Visual Analogue Scale(VAS)
Time Frame
Baseline/Week 8
Secondary Outcome Measure Information:
Title
Change from baseline to week 8 in Quality of Life(EQ-5D)
Time Frame
Baseline/Week 8
Title
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
Time Frame
Baseline/Week 8
Title
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
Time Frame
Baseline/Week 8
Title
Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
Time Frame
Baseline/Week 8
Title
Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
Time Frame
Baseline/Week 8
Title
Dose and frequency of Rescue medication(Acetaminophen)
Time Frame
Baseline/Week 8
Title
Number and proportion of subjects with adverse event
Time Frame
Baseline/Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon Jeong Ku
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Dankook University Hospital
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
31116
Country
Korea, Republic of
Facility Name
Catholic University of Korea's Bucheon St. Mary's Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Daejeon Eulji Medical Center, Eulji University
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
ZIP/Postal Code
30099
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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