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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624853
• Other study ID #: YMC042
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2023
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• pregabalin sustained release tablet
pregabalin sustained release tablet 150mg qd for 8weeks
• pregabalin immediate release capsule
pregabalin immediate release capsule 75mg bid for 8weeks

Locations

Country	Name	City	State
Korea, Republic of	Catholic University of Korea's Bucheon St. Mary's Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan	Chungcheongnam-do
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungcheongbuk-do
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Daejeon Eulji Medical Center, Eulji University	Daejeon
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 8 in Visual Analogue Scale(VAS)		Baseline/Week 8
Secondary	Change from baseline to week 8 in Quality of Life(EQ-5D)		Baseline/Week 8
Secondary	Change from baseline to week 8 in Patients Global Impression of Change(PGIC)		Baseline/Week 8
Secondary	Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)		Baseline/Week 8
Secondary	Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)		Baseline/Week 8
Secondary	Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)		Baseline/Week 8
Secondary	Dose and frequency of Rescue medication(Acetaminophen)		Baseline/Week 8
Secondary	Number and proportion of subjects with adverse event		Baseline/Week 8