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AzTrials

Helicobacter Pylori InfectionPhase 4NCT02466919

Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

A Phase 4 study testing Pantoprazole, Amoxicillin and Metronidazole in people with Helicobacter Pylori Infection, run by Chung-Tai Wu.

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

The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Pantoprazole, Amoxicillin and Metronidazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
No sites listed yet
Study dates
May 2014to Sep 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetic patients with Helicobacter pylori infection

Who cannot join

  • Pregnancy or physically poor performance status
  • Patients with contraindication for upper endoscopy
  • Severe coagulopathy for endoscopic biopsy
  • Chronic kidney disease (eGFR < 50) or end stage renal disease
  • Known allergy to interventional drugs
  • Previous eradication failure

About this study

Official title: Strategy on the Increment of H. Pylori Eradication Rate and Investigating the Gastric Pathology and Antimicrobial Resistance in Diabetic Patients

The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

Being tested
Pantoprazole, Amoxicillin, Metronidazole, Levofloxacin, Clarithromycin
Keywords
Helicobacter pylori

What participants receive

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

  • PantoprazoleDrug

    Also called Pantoloc

    1. pylori eradication therapy

  • AmoxicillinDrug

    1. pylori eradication therapy

  • MetronidazoleDrug

    Also called Flagyl

    1. pylori eradication therapy

  • LevofloxacinDrug

    Also called Cravit

    1. pylori eradication therapy

  • ClarithromycinDrug

    Also called Klaricid

    1. pylori eradication therapy
Study groups in NCT02466919
Study groupRoleWhat they receive
Levofloxacin-based concomitantExperimentalPantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
Receives: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Metronidazole; Drug: Levofloxacin
SequentialActive comparatorPantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10
Receives: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Metronidazole; Drug: Clarithromycin

What is being measured

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

  1. Helicobacter pylori eradication rate

    C13-UBT to confirm the H. pylori eradication

    Measured: 1-4 months after eradication therapy

Secondary outcomes (6)

  1. Acute inflammatory score

    Gastric tissue obtained from antrum (2 pieces), body (2 pieces) and cardia (1 piece) were scoring by modified Sydney system and specific staining. Acute inflammatory score (AIS) can be assessed by the sum of these five pathologic tissues

    Measured: 1-4 weeks after gastric tissue obtained by upper endoscopy

  2. Chronic inflammatory score

    Chronic inflammatory score (CIS) can be assessed by the sum of these five pathologic tissues

    Measured: 1-4 weeks after gastric tissue obtained by upper endoscopy

  3. H. pylori density score

    1. pylori density score (HPDS) can be assessed by the sum of these five pathologic tissues

    Measured: 1-4 weeks after gastric tissue obtained by upper endoscopy

  4. Intestinal metaplasia

    Presence of intestinal metaplasia can be evaluated from these five pathologic tissues

    Measured: 1-4 weeks after gastric tissue obtained by upper endoscopy

  5. Spasmolytic polypeptide expressing metaplasia

    Presence of spasmolytic polypeptide expressing metaplasia can be evaluated from these five pathologic tissues by special TFF-2 stains

    Measured: 1-4 weeks after gastric tissue obtained by upper endoscopy

  6. H. pylori resistance panel

    E-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance

    Measured: 1-4 weeks after H. pylori culture obtained by upper endoscopy

Timeline

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

  1. First posted9 Jun 2015 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466919
Sponsor's protocol ID
MOHW103-TDU-B-211-113002
Status last verified
Sep 2016
First submitted
17 May 2015
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Male non-insulin users with type 2 diabetes mellitus are predisposed to gastric corpus-predominant inflammation after H. pylori infection. J Biomed Sci. 2017 Oct 30;24(1):82. doi: 10.1186/s12929-017-0389-x.

    PubMed 29082856

  • Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes. Ann Med. 2017 Sep;49(6):479-486. doi: 10.1080/07853890.2017.1294761. Epub 2017 Mar 7.

    PubMed 28266875

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pantoprazole, Amoxicillin and Metronidazole in people with Helicobacter Pylori Infection, run by Chung-Tai Wu.

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 1 inclusion and 6 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 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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 eradication rate (time frame: 1-4 months after eradication therapy). 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 NCT02466919, which also lists 2 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 2 Sep 2016.

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