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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05624853
• Collaborator: (none)
• Enrollment: 130
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 31.6
• Patients Per Site: 16.3
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain; Diabetes Mellitus, Type 2	Drug: pregabalin sustained release tablet; Drug: pregabalin immediate release capsule	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 12, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline to week 8 in Visual Analogue Scale(VAS) [Baseline/Week 8]

Secondary Outcome Measures

1. Change from baseline to week 8 in Quality of Life(EQ-5D) [Baseline/Week 8]

2. Change from baseline to week 8 in Patients Global Impression of Change(PGIC) [Baseline/Week 8]

3. Change from baseline to week 8 in Clinician Global Impression of Change(CGIC) [Baseline/Week 8]

4. Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS) [Baseline/Week 8]

5. Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8) [Baseline/Week 8]

6. Dose and frequency of Rescue medication(Acetaminophen) [Baseline/Week 8]

7. Number and proportion of subjects with adverse event [Baseline/Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk National University Hospital	Cheongju	Chungcheongbuk-do	Korea, Republic of	28644
2	Dankook University Hospital	Cheonan	Chungcheongnam-do	Korea, Republic of	31116
3	Catholic University of Korea's Bucheon St. Mary's Hospital	Bucheon	Gyeonggi-do	Korea, Republic of	14647
4	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	48108
5	Kosin University Gospel Hospital	Busan		Korea, Republic of	49267
6	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015
7	Daejeon Eulji Medical Center, Eulji University	Daejeon		Korea, Republic of	35233
8	Chungnam National University Sejong Hospital	Sejong		Korea, Republic of	30099

Sponsors and Collaborators

• Yuhan Corporation

Investigators

• Principal Investigator: Bon Jeong Ku, Chungnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT05624853
• Other Study ID Numbers: YMC042
• First Posted: Nov 22, 2022
• Last Update Posted: Nov 22, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yuhan Corporation: pregabalin sustained release tablet
• Additional relevant MeSH terms: Neuralgia; Diabetes Mellitus, Type 2; Pregabalin

Study Results

No Results Posted as of Nov 22, 2022