A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy

NCT06383702 | Not Yet Recruiting Phase 3

• 1 other identifier: HEX1939-002
• Study Type: interventional
• Target: 358
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

  Week 13

Secondary Outcomes (7)

• NRS mean change at Weeks 1-12 and 14

  Weeks 1-12 and 14

• Proportion of subjects with NRS change

  Week 13

• Brief McGill Pain Questionnaire (SF-MPQ) score

  Weeks 1, 5, 9, 13, and 14

• Medical Outcomes Study Sleep Scale (MOS-SS) score

  Weeks 1, 5, 9, 13, and 14

• Hospital Anxiety and Depression Scale (HADS) score

  Weeks 1, 5, 9, 13, and 14

Study Arms (2)

Experimental: pregabalin sustained-release tablets

EXPERIMENTAL

Drug: pregabalin sustained-release tablets

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin sustained-release tablets DRUG

Subjects will take pregabalin sustained-release tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.

Experimental: pregabalin sustained-release tablets

Placebo DRUG

Subjects will take placebo tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel design

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: May 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04