Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jan 18, 2025

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ClinConnect Summary

This clinical trial is studying whether a medication called pregabalin, combined with moisturizing creams (emollients), can help reduce itching (pruritus) in people with Type 2 Diabetes. The researchers want to find out if this combination works better than a placebo (a dummy treatment that doesn't contain active medication) along with emollients. They will also look at how pregabalin affects the overall quality of life for participants suffering from itching.

To be eligible for the study, participants must be adults over 18 years old with Type 2 Diabetes and have had itching for at least six weeks. They should have a certain level of blood sugar control and not be using other medications that affect itching. Participants will take either pregabalin or a placebo once a day and visit the clinic for follow-up assessments at 4, 8, and 12 weeks, where their itching severity and overall improvement will be measured. This study could help determine if pregabalin is an effective treatment for itching related to diabetes, providing valuable information for managing this uncomfortable condition.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (\>18 years) with Type 2 Diabetes Mellitus
• • 2. HbA1c \<10% and on stable medication for at least 1 month before enrolment.
• • 3. Presence of chronic pruritus (lasting for six weeks or longer) \[2\].
• • 4. Generalized or localised pruritus affecting more than one major body area\*
• • 5. Baseline VAS score of ≥5 $ \*Pruritus including Generalized or localized pruritus as long as it involves two or more areas as per the 5D Itch Scale distribution \[Head/scalp, face, chest, abdomen, back, buttocks, thighs, lower legs, feet/toes, arms, palms, hands/fingers, groin, and clothing contact points (waistbands/undergarments).
• • $ Baseline VAS score of ≥5 is included to ensure sufficient severity of pruritus for measurable improvement.
• Exclusion Criteria:
• 1. Types of Diabetes:
• • o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.
• 2. Pruritus Duration and Causes:
• • Pruritus of less than six weeks' duration.
• • Pruritus associated with systemic conditions such as uraemia (CKD stage IV/V), cholestatic liver diseases, viral hepatitis, HIV infection, uncontrolled hypothyroidism\* or hyperthyroidism\^, myeloproliferative disorders, Chronic venous insufficiency in legs or Postherpetic pruritus.
• • \*Uncontrolled hypothyroidism - T3 / T4 below the upper limit of normal.
• • \^Uncontrolled hyperthyroidism- T3/T4 above the upper limit of normal.
• • Pruritus due to primary dermatological disorders presenting with skin lesions (e.g., atopic dermatitis, eczema, psoriasis, allergic contact dermatitis, urticarial disorders, lichen planus, prurigo nodularis, asteatotic dermatitis).
• 3. Use of Medications Affecting Pruritus:
• • o Current or recent use (within 2 weeks before study initiation) of systemic treatments that may impact pruritus, including gabapentins (e.g., pregabalin, gabapentin), tricyclic antidepressants (TCA), antihistamines, corticosteroids, and calcineurin inhibitors.
• • Rationale: Since these medications are commonly used for neuropathic pain or Pruritus which coexists with diabetic pruritus, their recent use may affect pruritus severity and treatment response. Patients using these drugs for neuropathic pain or other conditions should undergo a washout period of 2 weeks before study initiation.
• 4. Drug Hypersensitivity and Reactions:
• • o Known allergies or hypersensitivity to pregabalin or emollient.
• 5. Psychiatric and Immunocompromised Status:
• • Severe psychiatric disorders that may interfere with the evaluation of pruritus or adherence to the study protocol.
• • Immunocompromised patients (e.g., post-transplant, immunosuppressive therapy). Pruritus due to Notalgia paresthetica or brachioradial pruritus, post burn pruritus, opioid-induced pruritus.
• • 6. People with Substance abuse disorders.