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DyspepsiaPhase 4NCT02105090

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

A Phase 4 study testing Anesthetics, Local and Sodium Chloride 0.9% in people with Dyspepsia and Hematemesis, run by Helsinki University Central Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Dyspepsia, Hematemesis, Abdominal Pain
What is being tested?
Anesthetics, Local and Sodium Chloride 0.9%
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteFinland
Study dates
Oct 2014to Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective procedure
  • weight over 40 kg
  • American Society of Anesthesiology class I-III
  • first upper GI endoscopy procedure
  • finnish or/and swedish speaking

Who cannot join

  • 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
Show all 10Show fewer
  • chronic pain condition
  • chronic use of pain medication
  • pregnancy
  • lactation

Trial locations and contacts

1 site in 1 country.

Mihkel Meinberg, MD contact

+358504286766

mihkel.meinberg@hus.fi

Reino Pöyhiä, MD, PhD contact

+35894711

reino.poyhia@hus.fi

Finland1 site, 1 recruiting

  • Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital

    Helsinki, Uusimaa, 00029

    Mihkel Meinberg, MD, +358504286766, mihkel.meinberg@hus.fi

    Reino Pöyhiä, MD, PhD, +35894711, reino.poyhia@hus.fi

    Recruiting

Other trials in Finland

About this study

Official title: Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study

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.

Being tested
Anesthetics, Local, Sodium Chloride 0.9%
Keywords
Upper gastrointestinal tract, Endoscopy, Lozenge, Articaine, Dyspepsia, Hematemesis, Abdominal pain, Heartburn
Medical subject headings
Dyspepsia, Hematemesis, Abdominal Pain, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anesthetics, LocalDrug

    Also called Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

  • Sodium Chloride 0.9%Drug

Study groups in NCT02105090
Study groupRoleWhat they receive
Sodium chloride 0.9%Placebo comparatorSodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Receives: Drug: Sodium Chloride 0.9%
Articaine hydrochloride 1%ExperimentalArticaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Receives: Drug: Anesthetics, Local
Articaine hydrochloride 2%ExperimentalArticaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Receives: Drug: Anesthetics, Local

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 minutes after the procedure

Secondary outcomes (2)

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

    Measured: within 30 minutes after the procedure

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

    Measured: 30 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2019 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105090
Sponsor's protocol ID
2012-005528-13
Status last verified
May 2019
First submitted
29 Mar 2014
Last updated
6 May 2019
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anesthetics, Local and Sodium Chloride 0.9% in people with Dyspepsia and Hematemesis, run by Helsinki University Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mihkel Meinberg, MD (+358504286766, mihkel.meinberg@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02105090, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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