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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03087162
Other study ID # Psiriwat
Secondary ID
Status Completed
Phase Phase 4
First received February 9, 2017
Last updated April 2, 2018
Start date January 1, 2017
Est. completion date December 1, 2017

Study information

Verified date April 2018
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.


Description:

Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Age 18-75 year-patient

2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:

- Rapid urease test or Histology

3. Inform consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication

2. Contraindications or allergic reactions to the study drugs

3. Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases

4. Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30)

5. Mental disorders or alcohol or drug addiction

6. Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexlansoprazole 60 mg once daily
Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm

Locations

Country Name City State
Thailand Parin siriwat Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eradication rate (percentage) Compare eradication rate of helicobacter pylori between 2 groups Jan17-Nov17, Total 11 months
Secondary To compare drug compliance The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance. jan17-Nov17, Total 11 months
Secondary To compare drug adverse event The investigators measure adverse events as
Nausea/Vomiting
Abdominal pain/Abdominal discomfort/Abdominal Bloating
Diarrhea/ Constipation
Taste distortions
Headache/Dizziness
Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment.
jan17-Nov17, Total 11 months
See also
  Status Clinical Trial Phase
Recruiting NCT02576236 - Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection N/A
Recruiting NCT06275204 - H. Pylori Screen-and-treat Study in a Population of Young Adults