Clinical trial: Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease (NCT01493089)

Eligibility criteria:
Inclusion Criteria:

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

          1. Male or female, between 18 and 75 years old.

          2. 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.

          3. Have not taken on-demand PPI therapy for > 3 consecutive days within 4 weeks before
             the screening period.

          4. The patient's written informed consent must be obtained prior to inclusion.

          5. Willing and able to complete the entire procedure and to comply with study
             instructions.

          6. Females of childbearing potential must employ an adequate method of birth control.

        Inclusion criteria applicable to Screening period:

          1. 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.

          2. 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:

          1. Age < 18 or > 75 years old.

          2. 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.

          3. 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.

          4. Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or
             upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and
             polypectomy).

          5. 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.

          6. 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.

          7. Documented presence of severe renal or hepatic insufficiency.

          8. Known hypersensitivity to omeprazole.

          9. Concurrent participation in a study with an investigational drug or participation
             within 30 days of study entry.

         10. Females who are pregnant, or planning a pregnancy. Females of child bearing potential
             not using reliable methods of birth control.

         11. 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.

         12. 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.

         13. Taking concomitant medications that rely on the presence of gastric acid for optimal
             bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).

         14. 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:

          1. 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

          2. Completing < 90% (< 9 out of 10) of the time points with evaluable data on the e
             diary.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment