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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2022-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuropathic Pain Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pregabalin sustained release tablet

pregabalin sustained release tablet 150mg qd for 8weeks

Group Type EXPERIMENTAL

pregabalin sustained release tablet

Intervention Type DRUG

pregabalin sustained release tablet 150mg qd for 8weeks

pregabalin immediate release capsule

pregabalin immediate release capsule 75mg bid for 8weeks

Group Type ACTIVE_COMPARATOR

pregabalin immediate release capsule

Intervention Type DRUG

pregabalin immediate release capsule 75mg bid for 8weeks

Interventions

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pregabalin sustained release tablet

pregabalin sustained release tablet 150mg qd for 8weeks

Intervention Type DRUG

pregabalin immediate release capsule

pregabalin immediate release capsule 75mg bid for 8weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No