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OpenTrials
Completed

NCT Number: NCT02395458

Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

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.

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Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sequential therapy

Drug

Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days

Other names: Omeprazole-Amoxicillin-Clarithromycin-Metronidazole

triple therapy

Drug

Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days

Other names: Omeprazole-Clarithromycin-Metronidazole

Primary outcomes

  1. Eradication

    Time frame: 6 to 8 week after treatment

    Helicobacter pylori in gastric biopsy

Secondary outcomes

  1. Side effects

    Time frame: two weeks after beginning of treatment

    Nausea, vomiting, stomach ache

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2015
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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