AstraZeneca Clinical Trials

Losec™ (omeprazole) Clinical Trial Report Summaries

Losec™ (omeprazole) is a type of medicine known as an acid pump inhibitor (also known as a proton pump inhibitor, or PPI). By reducing acid production in the stomach, Losec™ reduces the amount of acid backing up into the esophagus and causing reflux symptoms.

Please consult the prescribing information for the country concerned for guidance on the approved use of Losec™ (omeprazole).

Losec Bibliography

Study Number	Completed Clinical Trial Report Summaries
D9584C00003	A histopathological evaluation of Helicobacter pylori eradication in patients treated in long-term compassionate use study with omeprazole (Losec®). An open study using two antibiotics with omeprazole for seven days or omeprazole alone and with long-term follow up.
D9584C00004 (I-635/SOPRAN)	Omeprazole versus anti-reflux surgery in the long-term management of reflux esophagitis: a 10-year follow up study of patients previously studied for 5 years - a Nordic multi-center study.
I-1113	Eradication of H. pylori or long-term acid suppression in duodenal ulcer disease. MAO Study (metronidazole/ amoxicillin/ omeprazole).A randomized trial with a two-year follow-up.
I-649	Recurrence of Stricture – Omeprazole’s Role Evaluated (RESTORE)
I-598-E	Omeprazole in the Long-Term Management of Duodenal Ulcers – A comparative study of omeprazole and ranitidine in high risk duodenal ulcer disease.
I-621	Omeprazole in the maintenance treatment of erosive peptic esophagitis: a double-blind, controlled study. Multicentre study in Australia including 5 centres.
I-653-B	A Randomized, Double‑Blind, Parallel-group, Placebo‑Controlled comparison of omeprazole 20 mg once daily, omeprazole 10 mg, and placebo in adult patients (18 – 80 years of age) with healed endoscopically-diagnosed gastro esophageal reflux disease (GERD) for 1 year or until relapse.
I-655	A comparative study of omeprazole and cimetidine on regression of columnar lined epithelium in patients with Barrett’s esophagus.
I-688-B	Prevention of symptom recurrence during maintenance treatment with omeprazole 10 mg once daily or ranitidine 150 mg b.i.d for twelve months.
I-901-B	Open treatment with omeprazole 40 mg once daily during 2-8 weeks and a twelve-month follow-up of the relapse rate of duodenal ulcer during maintenance treatment with omeprazole 20 mg once daily. A double blind multicentre placebo controlled study.
MK-764A-016	A Double-Blind Study to Evaluate the Effects of Omeprazole and an H₂ Antagonist in the Treatment of Barrett’s Esophagus.
I-613	Omeprazole and Ranitidine in the Treatment of Patients with Erosive Esophagitis Not Responding to Treatment withH2‑Receptor Antagonists: A Double-Blind, Controlled, Multicentre study.
I-665	Effects of elimination of gastro-esophageal reflux on omeprazole on parameters of pre-malignant change and de-differentiation (i.e. cell kinetics, and plasminogen activators), on classical histological criteria and further on the extent of Barrett’s epithelium.
I-900	Duodenal ulcer healing and relief of symptoms during treatment with omeprazole 20 or 40 mg once daily for 2-8 weeks (Study I-900a) Prevention of duodenal ulcer relapse during maintenance treatment with omeprazole 10 mg once daily, omeprazole 20 mg once daily, or ranitidine 150 mg for twelve months (Study I-900b)
I-904-B	Duodenal Ulcer Relapse During Maintenance Treatment With Omeprazole 20 mg, Omeprazole 10 mg, or Ranitidine 150 mg for Twelve Months
MK-764A-017	A multicenter, double-blind study to evaluate the safety and therapeutic efficacy of omeprazole 20 mg once daily or 10 mg once daily as compared to placebo during 12-24 months maintenance treatment of patients with duodenal ulcer healed following 4 weeks of omeprazole 20 mg once daily.