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Completed

NCT Number: 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

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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Key information

Conditions

Neuropathic Pain Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dankook University Hospital, Cheonan, Chungcheongnam-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 19 years, < 75 years
  • VAS score for diabetic peripheral neuropathy pain ≥ 30
  • Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
  • Type II DM patient and HbA1c ≤ 10 %
  • Written informed consent

Exclusion criteria

  • Patient with hypersensitivity to pregabalin
  • Patient on anti-epileptic drugs
  • Patients with pain caused by other factors than diabetic peripheral neuropathy
  • Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
  • Drug-abusing patient
  • Severe depression or uncontrolled abnormal mood and behavioral changes
  • Pregnant and breast-feeding woman
  • Patients who participated in other clinical trials for investigational products within 30 days of screening
  • Patients deemed to be ineligible to participate in the trial by investigator

Treatment and study plan

pregabalin sustained release tablet

Drug

pregabalin sustained release tablet 150mg qd for 8weeks

pregabalin immediate release capsule

Drug

pregabalin immediate release capsule 75mg bid for 8weeks

Primary outcomes

  1. Change from baseline to week 8 in Visual Analogue Scale(VAS)

    Time frame: Baseline/Week 8

Secondary outcomes

  1. Change from baseline to week 8 in Quality of Life(EQ-5D)

    Time frame: Baseline/Week 8

  2. Change from baseline to week 8 in Patients Global Impression of Change(PGIC)

    Time frame: Baseline/Week 8

  3. Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)

    Time frame: Baseline/Week 8

  4. Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)

    Time frame: Baseline/Week 8

  5. Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)

    Time frame: Baseline/Week 8

  6. Dose and frequency of Rescue medication(Acetaminophen)

    Time frame: Baseline/Week 8

  7. Number and proportion of subjects with adverse event

    Time frame: Baseline/Week 8

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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