ClinicalTrials.gg
Status unknownNCT02105090Updated May 6, 2019

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

A Phase 4 interventional study of Anesthetics, Local and Sodium Chloride 0.9% in Dyspepsia, Hematemesis and Abdominal Pain, sponsored by Helsinki University Central Hospital. Status unknown at 1 site in Finland. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspepsia
  • Hematemesis
  • Abdominal Pain
  • Heartburn

Keywords

  • Upper gastrointestinal tract
  • Endoscopy
  • Lozenge
  • Articaine
  • Dyspepsia
  • Hematemesis
  • Abdominal pain
  • Heartburn
03

In context

Dyspepsia

372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.

This study's planned enrollment of 120 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • amide and/or esther local anaesthetic allergy
  • paraben allergy
  • grade B/C liver failure
  • renal insufficiency (calculated under 60 ml/min/1.73 m2 according to scale )
  • dementia
  • those presenting with swallowing problem
  • chronic pain condition
  • chronic use of pain medication
  • pregnancy
  • lactation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Placebo comparator
    Sodium chloride 0.9%

    Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

    Drug: Sodium Chloride 0.9%

  • Experimental
    Articaine hydrochloride 1%

    Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

    Drug: Anesthetics, Local

  • Experimental
    Articaine hydrochloride 2%

    Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

    Drug: Anesthetics, Local

Interventions

  • Also known as: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

  • DrugSodium Chloride 0.9%
06

What researchers measure

Primary outcomes

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

    Time frame: 30 minutes after the procedure

Secondary outcomes

  1. Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)

    Time frame: within 30 minutes after the procedure

  2. Cumulative consumption of alfentanil during the procedure (mg)

    Time frame: 30 minutes after the procedure

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
    Helsinki, Uusimaa 00029, Finland
    Recruiting
    • Mihkel Meinberg, MD · Contactmihkel.meinberg@hus.fi · +358504286766
    • Reino Pöyhiä, MD, PhD · Contactreino.poyhia@hus.fi · +35894711
    • Mihkel Meinberg, MD · Principal investigator
    • Kalle Jokelainen, MD, PhD · Sub investigator
    • Harri Mustonen, MD, PhD · Sub investigator
    • Hannamari Hakojärvi, Pharm.D · Sub investigator
    • Anne Juppo, Pharm.D, PhD · Sub investigator
    • Pertti Pere, MD, PhD · Sub investigator
08

References and documents

Publications

  • Campo R, Brullet E, Montserrat A, Calvet X, Moix J, Rue M, Roque M, Donoso L, Bordas JM. Identification of factors that influence tolerance of upper gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):201-4. doi: 10.1097/00042737-199902000-00023. PubMed 10102233 ↗
  • Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6. doi: 10.1111/j.1572-0241.1999.01217.x. PubMed 10406247 ↗
  • Shaoul R, Higaze H, Lavy A. Evaluation of topical pharyngeal anaesthesia by benzocaine lozenge for upper endoscopy. Aliment Pharmacol Ther. 2006 Aug 15;24(4):687-94. doi: 10.1111/j.1365-2036.2006.03023.x. PubMed 16907901 ↗
  • Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059. PubMed 16650534 ↗
  • Asante MA, Northfield TC. Variation in taste of topical lignocaine anaesthesia for gastroscopy. Aliment Pharmacol Ther. 1998 Jul;12(7):685-6. doi: 10.1046/j.1365-2036.1998.00355.x. PubMed 9701534 ↗
  • Mogensen S, Treldal C, Feldager E, Pulis S, Jacobsen J, Andersen O, Rasmussen M. New lidocaine lozenge as topical anesthesia compared to lidocaine viscous oral solution before upper gastrointestinal endoscopy. Local Reg Anesth. 2012;5:17-22. doi: 10.2147/LRA.S30715. Epub 2012 May 31. PubMed 22915898 ↗
  • Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006. PubMed 15966499 ↗
  • Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16. doi: 10.1111/j.1399-6576.1977.tb01186.x. PubMed 320810 ↗
  • Kallio H, Snall EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. doi: 10.1093/bja/ael222. Epub 2006 Aug 5. PubMed 16891634 ↗
  • Pitkanen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5. PubMed 10204898 ↗
  • Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607. PubMed 10599952 ↗
  • Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4. doi: 10.1016/s0378-4347(00)81126-3. No abstract available. PubMed 3372637 ↗
  • Prout BJ, Metreweli C. Pulmonary aspiration after fibre-endoscopy of the upper gastrointestinal tract. Br Med J. 1972 Nov 4;4(5835):269-71. doi: 10.1136/bmj.4.5835.269. PubMed 4343464 ↗
  • Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. doi: 10.2165/00003088-199733060-00002. PubMed 9435991 ↗
  • Simon MA, Vree TB, Gielen MJ, Booij LH. Comparison of the effects and disposition kinetics of articaine and lidocaine in 20 patients undergoing intravenous regional anaesthesia during day case surgery. Pharm World Sci. 1998 Apr;20(2):88-92. doi: 10.1023/a:1008622018161. PubMed 9584343 ↗
  • Alhashemi JA. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006 Jun;96(6):722-6. doi: 10.1093/bja/ael080. Epub 2006 Apr 4. PubMed 16595611 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02105090
Responsible party
Mihkel Meinberg (MD, Helsinki University Central Hospital) — Principal investigator
First posted
Apr 7, 2014
Start date
Oct 2014
Primary completion
Dec 2019 (estimated)
Completion
Sep 2020 (estimated)
Last update
May 6, 2019

Study contacts

Mihkel Meinberg, MD
Contact
mihkel.meinberg@hus.fi
+358504286766
Reino Pöyhiä, MD, PhD
Contact
reino.poyhia@hus.fi
+35894711
Mihkel Meinberg, MD
principal investigator · Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Reino Pöyhiä, MD, PhD
study chair · Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Local anesthetics

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