Could a nerve pain drug stop diabetic itching?

NCT ID NCT06790537

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether pregabalin, a drug used for nerve pain, can reduce chronic itching in people with type 2 diabetes. 46 adults will receive either pregabalin plus moisturizer or a placebo plus moisturizer for 12 weeks. Researchers will measure itching severity and quality of life at follow-up visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pregabalin
What this could lead to
If it works, this could offer a new treatment option for chronic itching in people with diabetes.
What could go wrong
This is a small, early-phase trial with only 46 participants, so results may not apply to everyone. Pregabalin can cause dizziness and drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology , PGIMER, Chandigarh

    NOT_YET_RECRUITING

    Chandigarh, Chandigarh, 160012, India

  • Department of Endocrinology , PGIMER, Chandigarh

    RECRUITING

    Chandigarh, Chandigarh, 160012, India

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