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Pain-Free shots? study tests if preservative is the culprit

NCT ID NCT07600814

Knowledge-focused Sponsor: Medical University of Vienna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial investigates whether m-Cresol, a preservative used in many injectable medications like insulin, causes pain at the injection site. Eighteen healthy volunteers will receive three injections in their belly: one with a low concentration of m-Cresol, one with a higher concentration, and one without the preservative. They will rate their pain every 5 seconds until it stops. The goal is to see if m-Cresol is a major source of injection pain, which could lead to more comfortable drug formulations.

What this could mean

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

Active substance
m-Cresol (a preservative used in injectable medications)
What this could lead to
If this trial shows m-Cresol causes pain, it could lead to reformulating common injectable drugs like insulin to be less painful, improving patient comfort and adherence.
What could go wrong
This is a very early, small study in only 18 healthy volunteers, not patients. The results may not reflect real-world use or lead to immediate changes in drug formulations.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 18 people

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

Expected to start

May 2026

An estimate. Start dates often move.

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 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * Age between 18 and 70 years * Full legal capacity Exclusion criteria * Participant of another study, ongoing or within the last four weeks * Current medication intake (except hormonal contraception) or drug abuse * Female subjects: Positive pregnancy test or breastfeeding * Body temperature above 38°C, verified by infrared thermometer * Known allergic diseases, in particular asthmatic disorders and skin diseases * Sensory deficit, skin disease or hematoma of unknown origin in the examination of the test site

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain

As listed by the trial registrant

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

Acute pain Healthy volunteer study Pain

How to take part

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

  1. 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 ↗

  2. 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.

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Other studies related to the condition(s) this trial covers.