Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Helicobacter Infections Clinical Trial

Official title:

Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395458
• Other study ID #: R-2013-3609-22
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2015
• Last updated: March 17, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.

Description:

In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Helicobacter pylori infection in biopsy

• Eradication required

Exclusion Criteria:

• Antibiotic received two weeks prior

• Previous treatment for H pylori infection

• Allergy to any of the treatment drugs

• Smoking > 5 cigarettes daily.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections

Intervention

Drug:
• Sequential therapy
Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
• Triple therapy
Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication	Helicobacter pylori in gastric biopsy	6 to 8 week after treatment	No
Secondary	Side effects	Nausea, vomiting, stomach ache	two weeks after beginning of treatment	No