Prospective Randomized Trial of Esomeprazole versus Lansoprazole and Omeprazole Based Triple Therapy for H. Pylori Eradication in an Iranian Population

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201204043836N4

Enrollment

300

Registered

2012-06-07

Start date

2012-04-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

peptic ulcer-gastritis-non ulcer dyspepsia. Gastric ulcer-Duodenal ulcer-Gastritis, unspecified-Dyspepsia

Interventions

Intervention 1: Group I: 100 patients receive Omperazole 20mg bid, Clarithromycin 500mg bid and Amoxicillin 1000mg bid.(OCA regimen). Intervention 2: Group II: 100 patients will recive Lansoprazole

Treatment - Drugs

Group I: 100 patients receive Omperazole 20mg bid, Clarithromycin 500mg bid and Amoxicillin 1000mg bid.(OCA regimen)

Group II: 100 patients will recive Lansoprazole 30mg bid, Clarithromycin 500mg bid and Amoxicillin 1000mg bid.(LCA regimen)

Group III(NCA) : 100 patients will recive Esomeprazole (Nexium) 40mg bid, Clarithromycin 500mg bid and Amoxicillin 1 gram bid.

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with endoscopic evidence of peptic ulcer, non-ulcer dyspepsia, gastritis or acid reflux with confirmation H. Pylori, either by histology or a positive Urease test will enroll in the study. Exclusion criteria: previous treatment of H. Pylori infection; previous use of any antibiotics or bismuth subcitrate or any PPI or H2 blocker within four weeks prior to endoscopy; use of NSAIDs for more than four weeks; history of allergy to medications; previous history of any gastric surgery; underlying diseases such as cirrhosis or, uremia and pregnancy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Eradication helicobacter pylori. Timepoint: 4 weeks. Method of measurement: Urea breath test.	—

Secondary

Measure	Time frame
Side effects will systematically record throughout the study and will assess using a checklist administered by a physician. Timepoint: During study. Method of measurement: 1-None or only mild: mild discomfort which dont interfere with the patients’ normal daily activities. 2-Intermediate: discomfort or side effects which interfered with the patients’ normal daily activities. 3-Severe: side effects requiring cessation of treatment.	—

Measure

Time frame

Side effects will systematically record throughout the study and will assess using a checklist administered by a physician. Timepoint: During study. Method of measurement: 1-None or only mild: mild discomfort which dont interfere with the patients’ normal daily activities. 2-Intermediate: discomfort or side effects which interfered with the patients’ normal daily activities. 3-Severe: side effects requiring cessation of treatment.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdolrahim Masjedizadeh

Imam Hospital

masjedi-r@ajums.ac.ir+98 61 1222 2922

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026