UnknownPhase 4

Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy

Finland120 participantsStarted 2014-10

Plain-language summary

The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * elective procedure * weight over 40 kg * American Society of Anesthesiology class I-III * first upper GI endoscopy procedure * finnish or/and swedish speaking Exclusion Criteria: * amide and/or esther local anaesthetic allergy * paraben allergy * Child-Pugh grade B/C liver failure * renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale ) * dementia * those presenting with swallowing problem * chronic pain condition * chronic use of pain medication * pregnancy * lactation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).

Timeframe: 30 minutes after the procedure

Trial details

NCT IDNCT02105090

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Mihkel Meinberg, MD

+358504286766 mihkel.meinberg@hus.fi

View on ClinicalTrials.gov More Dyspepsia trials

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.