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THE EFFECT OF NEXIUM (ESOMEPRAZOL) MORE CLARITHROMYCIN AND AMOXICILLIN FOR A WEEK COMPARED WITH CONVENTIONAL THERAPY OF LOSEC (OMEPRAZOL) FOR 1 WEEK WITH FOLLOWING MONOTHERAPY FOR THREE WEEKS FOR THE TREATMENT OF THE ERADICATION OF HELICOBACTER PYLORI AND SCATTERING OF THE DUODENAL ULCER , BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER, MULTINATIONAL EMSDO STUDY

THE EFFECT OF NEXIUM (ESOMEPRAZOL) MORE CLARITHROMYCIN AND AMOXICILLIN FOR A WEEK COMPARED WITH CONVENTIONAL THERAPY OF LOSEC (OMEPRAZOL) FOR 1 WEEK WITH FOLLOWING MONOTHERAPY FOR THREE WEEKS FOR THE TREATMENT OF THE ERADICATION OF HELICOBACTER PYLORI AND SCATTERING OF THE DUODENAL ULCER , BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER, MULTINATIONAL EMSDO STUDY.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-002-02
Enrollment
340
Registered
2002-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP I Type of group
You will be given esomeprazole 20mg b.i.d. more amoxicillin 1000 mg b.i.d. plus clarithromycin 500 mg b.i.d for one week, then placebo for 4 weeks and endoscopy. if it has healed, a urea breath test and endoscopy will be performed at week 8. Group name:GROUP II Type of group
You will be given omeprazole 20mg b.i.d. more amoxicillin 1000 mg b.i.d. plus clarithromycin 500 mg b.i.d for one week, then omeprazole for 4 weeks and endoscopy. if it has healed, a urea breath test and endoscopy will be performed at week 8.

Sponsors

ASTRAZENECA - PERU,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Active duodenal ulcer of at least 5 mm in diameter verified by endoscopy. 2. Positive diagnosis for Helicobacter pylori on admission using the urea test for Helicobacter (TUH). 3. Signed Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years, 2. Gastric, pre-pyloric or current pyloric ulcer. 3. Current complication of duodenal ulcer disease. 4. Need for concomitant medications for symptoms related to heartburn and / or peptic ulcer disease. 5. Contraindications to study drugs, including allergy or suspected or known hypersensitivity to study drugs. 6. Treatment with NSAIDs during the two weeks prior to inclusion. 7. More than one previous attempt to eradicate H. pylori. 8. Attempt to eradicate within 6 months prior to inclusion.

Countries

Arabia Saudi, Chile, Colombia, Peru, United States, Uruguay, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)