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Tests treatment safety and results for Diabetic Pruritus
Official title Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
ClinicalTrials.gov ID: NCT06790537
What this study is testing
What is Pregabalin 75 mg?
Pregabalin 75 mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diabetic pruritus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Brief Summary: The goal of this randomized controlled study is to learn if pregabalin combined with emollients can reduce pruritus (itching) in people with Type 2 Diabetes Mellitus. The main questions it aims to answer are: Does pregabalin combined with emollients reduce pruritus severity compared to a placebo combined with emollients?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (\>18 years) with Type 2 Diabetes Mellitus
- HbA1c \<10% and on stable medication for at least 1 month before enrolment.
- Presence of chronic pruritus (lasting for six weeks or longer) [2].
- Generalized or localised pruritus affecting more than one major body area\
- 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...
You likely can't join if
- Types of Diabetes: o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.
- 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...
- Pruritus due to primary dermatological disorders presenting with skin lesions (e.g., atopic dermatitis, eczema, psoriasis, allergic contact...
- Use of Medications Affecting Pruritus: o Current or recent use (within 2 weeks before study initiation) of systemic treatments that may impact...
See the full eligibility criteria
- Adults (\>18 years) with Type 2 Diabetes Mellitus
- HbA1c \<10% and on stable medication for at least 1 month before enrolment.
- Presence of chronic pruritus (lasting for six weeks or longer) [2].
- Generalized or localised pruritus affecting more than one major body area\
- 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...
- Types of Diabetes: o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.
- 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...
- 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...
- 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...
- Drug Hypersensitivity and Reactions: o Known allergies or hypersensitivity to pregabalin or emollient.
- 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.
- People with Substance abuse disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, Chandigarh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.