A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy

Launched by CSPC OUYI PHARMACEUTICAL CO., LTD. · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pregabalin, which is being tested in its extended-release form to help manage pain caused by diabetic peripheral neuropathy. This type of pain is a common complication for people with diabetes, where nerve damage leads to discomfort in the feet and legs. The trial aims to see how effective and safe this once-daily medication is compared to other forms of pregabalin, making it easier for patients to stick to their treatment plan.

To be eligible for the study, participants need to be between 18 and 75 years old and have been diagnosed with diabetes for at least one year. They should also have experienced nerve pain for at least six months due to diabetes. However, individuals with certain other health conditions or those who are pregnant or breastfeeding cannot participate. If you join the trial, you'll take pregabalin once a day after dinner, and your progress will be monitored by healthcare professionals. This could be a great opportunity for those struggling with diabetic nerve pain to potentially find relief while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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.