Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease

Inclusion criteria

Study patients will be included in the study if they satisfy the following criteria:

• Male or female, between 18 and 75 years old.
• History of frequent episodes of heartburn associated with GERD for at least 2 3 days per week during 2-4 weeks before screening and have responded to standard PPI therapy in the past 12 months.
• Have not taken on-demand PPI therapy for > 3 consecutive days within 4 weeks before the screening period.
• The patient's written informed consent must be obtained prior to inclusion.
• Willing and able to complete the entire procedure and to comply with study instructions.
• Females of childbearing potential must employ an adequate method of birth control.

Inclusion criteria

applicable to Screening period:

• Recorded at least 1 evaluable episode of heartburn on 2 separate days at level 4 or higher on the 9-point Likert severity scale (point 3 on a 0-8 point scale) prior to randomisation.
• Competent in the use and completion of the e-diary.

Exclusion criteria

Study patients will be excluded if they meet any of the following criteria:

• Age < 18 or > 75 years old.
• Intake of any medication for the purpose of the eradication of Helicobacter pylori (H. pylori) during the last 28 days before the start of the study.
• Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
• Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and polypectomy).
• History of co-existing disease that affects the oesophagus (e.g. Barrett's oesophagus, Zollinger-Ellison syndrome, oesophageal stricture), and have undergone an endoscopy with results of incomplete healing of erosions following standard PPI therapy within the last 3 months.
• History of active gastric or duodenal ulcers within 3 months of the first dose of the study drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
• Documented presence of severe renal or hepatic insufficiency.
• Known hypersensitivity to omeprazole.
• Concurrent participation in a study with an investigational drug or participation within 30 days of study entry.
• Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control.
• Clinically significant laboratory abnormality or disease which, in the opinion of the Investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.
• Received or require any of the following drugs within 2 weeks before the first dose of study or continue to need these drugs for concurrent therapy: theophylline, bismuth salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram, benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate, clopidogrel or protease inhibitors.
• Taking concomitant medications that rely on the presence of gastric acid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
• Onset of psychoactive medication (e.g. depressants, stimulants or hallucinogens) in the previous 6 months and during the entire course of the study.

Exclusion criteria

applicable to Screening period:

• Recorded < 1 episode of heartburn on 2 separate days at level 4 on the 9 point Likert severity scale (point 3 on a 0-8 point scale) during the 7 day screening period prior to randomisation
• Completing < 90% (< 9 out of 10) of the time points with evaluable data on the e diary.