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Helicobacter Pylori InfectionPhase 2/3NCT05861687

Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

A Phase 2/3 study testing Esomeprazole, Lansoprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Finni Kollins at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Esomeprazole, Lansoprazole and Amoxicillin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesIndonesia
Study dates
1 Aug 2021to 20 May 2022
Phase
Phase 2/3
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 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena)
  • Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing

Who cannot join

  • subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (NSAIDs) within 14 days prior to surgery
  • subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment
  • Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Universitas Sumatera Utara General Hospital

    Medan, North Sumatera, 20124

  • Haji Adam Malik General Hospital

    Medan, North Sumatera, 20136

Other trials in Indonesia

About this study

Official title: Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials

This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole

Read the detailed description
  1. pylori eradication therapy is still contentious. A treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended.

PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.

Being tested
Esomeprazole, Lansoprazole, Amoxicillin, Clarithromycin
Keywords
Helicobacter pylori, Triple therapy, Children, Esomeprazole, Lansoprazole

What participants receive

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

  • EsomeprazoleDrug

    Administered once a day per-oral (PO) with the dose of 0.4 mg/kg

  • LansoprazoleDrug

    Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was <30 kg, and 30 mg if it was >30 kg

  • AmoxicillinDrug

    Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

  • ClarithromycinDrug

    Administered twice a day per-oral with the dose of 7.5 mg/kg

Study groups in NCT05861687
Study groupRoleWhat they receive
Esomeprazole in combination with Amoxicillin and ClarithromycinExperimentalEsomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Receives: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin
Lansoprazole in combination with Amoxicillin and ClarithromycinActive comparatorLansoprazole: once a day per oral; 15 mg if body weight < 30 kg and 30 mg if body weight > 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Receives: Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin

What is being measured

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

  1. Helicobacter pylori Stool Antigen Test

    The stool of the subjects will be assessed on day-15 after drug administration. A negative result indicates that patient is infection-free

    Measured: 15 days

Secondary outcomes (1)

  1. Helicobacter pylori Stool Antigen Test

    The stool of the subjects will be analyzed on day-90 after drug administration to assess whether a reinfection is present. A negative result indicates that patient is infection-free

    Measured: 75 days

Timeline

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

  1. First posted17 May 2023
  2. Study start1 Aug 2021
  3. Primary completion7 Dec 2021
  4. Study completion20 May 2022

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861687
Sponsor's protocol ID
LB.02.01.XV.III.2.2.2/344/2022
Status last verified
May 2023
First submitted
6 May 2023
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Awuku YA, Simpong DL, Alhassan IK, Tuoyire DA, Afaa T, Adu P. Prevalence of helicobacter pylori infection among children living in a rural setting in Sub-Saharan Africa. BMC Public Health. 2017 Apr 24;17(1):360. doi: 10.1186/s12889-017-4274-z.

    PubMed 28438158

  • Jafar S, Jalil A, Soheila N, Sirous S. Prevalence of helicobacter pylori infection in children, a population-based cross-sectional study in west iran. Iran J Pediatr. 2013 Feb;23(1):13-8.

    PubMed 23550042

  • Allen SJ, Thomas JE, Alexander ND, Bailey R, Emerson PM. Flies and Helicobacter pylori infection. Arch Dis Child. 2004 Nov;89(11):1037-8. doi: 10.1136/adc.2003.045880.

    PubMed 15499059

  • Mansour MM, Al Hadidi KhM, Omar MA. Helicobacter pylori and recurrent abdominal pain in children: is there any relation? Trop Gastroenterol. 2012 Jan-Mar;33(1):55-61. doi: 10.7869/tg.2012.9.

    PubMed 22803297

  • Das BK, Kakkar S, Dixit VK, Kumar M, Nath G, Mishra OP. Helicobacter pylori infection and recurrent abdominal pain in children. J Trop Pediatr. 2003 Aug;49(4):250-2. doi: 10.1093/tropej/49.4.250.

    PubMed 12929890

  • Quek SH. Recurrent abdominal pain in children: a clinical approach. Singapore Med J. 2015 Mar;56(3):125-8; quiz 132. doi: 10.11622/smedj.2015038.

    PubMed 25820843

  • Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.

    PubMed 28541262

  • Urgesi R, Cianci R, Riccioni ME. Update on triple therapy for eradication of Helicobacter pylori: current status of the art. Clin Exp Gastroenterol. 2012;5:151-7. doi: 10.2147/CEG.S25416. Epub 2012 Sep 17.

    PubMed 23028235

  • Sahara S, Sugimoto M, Uotani T, Ichikawa H, Yamade M, Iwaizumi M, Yamada T, Osawa S, Sugimoto K, Umemura K, Miyajima H, Furuta T. Twice-daily dosing of esomeprazole effectively inhibits acid secretion in CYP2C19 rapid metabolisers compared with twice-daily omeprazole, rabeprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Nov;38(9):1129-37. doi: 10.1111/apt.12492. Epub 2013 Sep 16.

    PubMed 24099474

  • Peterson WL. The role of antisecretory drugs in the treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 1997 Apr;11 Suppl 1:21-5. doi: 10.1046/j.1365-2036.11.s1.4.x.

    PubMed 9146787

  • Ward RM, Kearns GL. Proton pump inhibitors in pediatrics : mechanism of action, pharmacokinetics, pharmacogenetics, and pharmacodynamics. Paediatr Drugs. 2013 Apr;15(2):119-31. doi: 10.1007/s40272-013-0012-x.

    PubMed 23512128

  • Nishida T, Tsujii M, Tanimura H, Tsutsui S, Tsuji S, Takeda A, Inoue A, Fukui H, Yoshio T, Kishida O, Ogawa H, Oshita M, Kobayashi I, Zushi S, Ichiba M, Uenoyama N, Yasunaga Y, Ishihara R, Yura M, Komori M, Egawa S, Iijima H, Takehara T. Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan. World J Gastroenterol. 2014 Apr 21;20(15):4362-9. doi: 10.3748/wjg.v20.i15.4362.

    PubMed 24764674

  • Niv Y. H pylori recurrence after successful eradication. World J Gastroenterol. 2008 Mar 14;14(10):1477-8. doi: 10.3748/wjg.14.1477.

    PubMed 18330934

  • Halitim F, Vincent P, Michaud L, Kalach N, Guimber D, Boman F, Turck D, Gottrand F. High rate of Helicobacter pylori reinfection in children and adolescents. Helicobacter. 2006 Jun;11(3):168-72. doi: 10.1111/j.1523-5378.2006.00396.x.

    PubMed 16684264

  • Ding Z, Zhao S, Gong S, Li Z, Mao M, Xu X, Zhou L. Prevalence and risk factors of Helicobacter pylori infection in asymptomatic Chinese children: a prospective, cross-sectional, population-based study. Aliment Pharmacol Ther. 2015 Oct;42(8):1019-26. doi: 10.1111/apt.13364. Epub 2015 Aug 14.

    PubMed 26271484

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Esomeprazole, Lansoprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Finni Kollins at 2 sites in Indonesia.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Helicobacter pylori Stool Antigen Test (time frame: 15 days). 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 NCT05861687, which also lists 29 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 17 May 2023.

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