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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Neuropathic Pain
• Interventions: Drug: pregabalin sustained release tablet; Drug: pregabalin immediate release capsule

• Registration Number: NCT05624853
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-22
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin sustained release tablet	pregabalin sustained release tablet	pregabalin sustained release tablet 150mg qd for 8weeks
pregabalin immediate release capsule	pregabalin immediate release capsule	pregabalin immediate release capsule 75mg bid for 8weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 8 in Visual Analogue Scale(VAS)	Baseline/Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)	Baseline/Week 8
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)	Baseline/Week 8
Dose and frequency of Rescue medication(Acetaminophen)	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
Change from baseline to week 8 in Quality of Life(EQ-5D)	Baseline/Week 8
Number and proportion of subjects with adverse event	Baseline/Week 8

Trial Locations

Locations (8)

Dankook University Hospital; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Chungcheongbuk-do, Korea, Republic of

Daejeon Eulji Medical Center, Eulji University; 🇰🇷 Daejeon, Korea, Republic of

Chungnam National University Sejong Hospital; 🇰🇷 Sejong, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Catholic University of Korea's Bucheon St. Mary's Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of