Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

H Pylori Eradication Clinical Trial

Official title:

Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087162
• Other study ID #: Psiriwat
• 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
• 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

Related Conditions & MeSH terms

• H Pylori Eradication

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