Clinical trial NCT05624853: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Diabetes Mellitus, Type 2
Keywords: pregabalin sustained release tablet
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to week 8 in Visual Analogue Scale(VAS)
timeFrame: Baseline/Week 8
Secondary outcomes:
measure: Change from baseline to week 8 in Quality of Life(EQ-5D)
timeFrame: Baseline/Week 8
measure: Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
timeFrame: Baseline/Week 8
measure: Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
timeFrame: Baseline/Week 8
measure: Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
timeFrame: Baseline/Week 8
measure: Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
timeFrame: Baseline/Week 8
measure: Dose and frequency of Rescue medication(Acetaminophen)
timeFrame: Baseline/Week 8
measure: Number and proportion of subjects with adverse event
timeFrame: Baseline/Week 8
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Catholic University of Korea's Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center, Eulji University
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
Study officials:
affiliation: Chungnam National University Hospital
name: Bon Jeong Ku
role: PRINCIPAL_INVESTIGATOR
References: