A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy

Phase 3Not Yet RecruitingNCT06383702

CSPC Ouyi Pharmaceutical Co., Ltd.358 enrolled

Overview

This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.

This is a multicenter, randomized, double-blind, placebo-controlled trial, the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. The study includes a screening period (3 weeks, including baseline/run-in period), a treatment period (titration period, fixed dose period and withdrawal period), and a follow-up period. During the treatment period participants will receive pregabalin sustained-release tablets/placebo as daily treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

358

Conditions

Painful Diabetic Neuropathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥ 18 years and ≤ 75 years at screening; * diagnosed with type 1 or type 2 diabetes for ≥ 1 year; * diagnosed with distal symmetrical polyneuropathy caused by diabetes (type 1 or type 2), with duration of neuropathic pain associated with diabetic peripheral neuropathy ≥ 6 months; * clearly understood and voluntarily participated in the study, and signed the informed consent form by themselves. Exclusion Criteria: * Subjects with other conditions that may confound the assessment of Neuropathic Pain associated with Diabetic Peripheral neuropathy (DPNP), such as: neuropathic pain other than DPNP (cervical spondylosis, carpal tunnel syndrome, spinal stenosis, postherpetic pain, etc.), pain caused by other causes (gout, chronic obstructive arteriosclerosis, arthritis, etc.), and other pain at the assessment site (skin diseases and trauma); * subjects with known or suspected allergic reactions to various components of pregabalin sustained-release tablets or compounds closely related to paracetamol or paracetamol; * subjects with clinically significant or unstable diseases, such as but not limited to severe cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system diseases, inflammatory or rheumatic diseases, uncontrolled infection, untreated endocrine diseases, etc., and other conditions that judged by the investigator to influence participation in the trial; * subjects who have undergone renal transplantation, or are undergoing renal dialysis; * subjects with uncontrolled narrow-angle glaucoma, uncontrolled seizure history, or uncontrolled or poorly controlled hypertension; * Pregnant or lactating females or subjects planning to father a child during the trial (including males); * subjects with a history of drug or alcohol abuse within one year prior to screening; patients who, in the opinion of the investigator, are not suitable for participation in this trial.

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) mean change at week 13.

The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean of NRS (numeric rating scale) at week 13 will be recorded

Time frame: Week 13

Secondary Outcomes

NRS mean change at Weeks 1-12 and 14

The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean NRS pain score at Weeks 1-12 and 14 during the treatment period will be recorded;

Time frame: Weeks 1-12 and 14

Proportion of subjects with NRS change

The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Proportion of subjects with ≥ 50% and ≥ 30% change from baseline in weekly mean NRS pain score at Week 13 will be recorded;

Time frame: Week 13

Brief McGill Pain Questionnaire (SF-MPQ) score

It is a self-report questionnaire that allows individuals to give their doctor a good description of the quality and intensity of pain that they are experiencing. Users first select a single word from each group that best reflects their pain; then respondents specify their level of pain by indicating a position along a continuous line between two end-points; then subjects chose the numer best represent their current pain intensity (0\~5). Change from baseline in SF-MPQ (Brief McGill Pain Questionnaire) total score and each subscale Pain Grading Index (PRI), Visual Analogue Scale (VAS), and Present Pain Intensity (PPI) scores at Weeks 1, 5, 9, 13, and 14 after treatment;