E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heartburn associated with gastro-oesophageal reflux disease (GERD) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to compare Zegerid 20 mg suspension to Losec 20 mg capsule in terms of the median time to sustained reduction of severity of heartburn associated with GERD, which is sustained for 45 minutes or more. |
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E.2.2 | Secondary objectives of the trial |
Key secondary objetives: 1. Determine the median time to sustained partial response 2. Determine the median time to sustained total relief from heartburn, which is sustained for 45 minutes or more. 3. Determine the proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 45, 60 and 90 minutes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion 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. Competence in the use and completion of the e-diary. |
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E.4 | Principal exclusion criteria |
1. Age <18 or >75 years old. 2. Intake of any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study. 3. Intake of systemic glucocorticoids or 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 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 (the use of the combined oral pill, progestogen only pill, combined contraceptive patches, depot contraceptives or double barrier method all are acceptable as a reliable form of contraception). 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 any of the following drugs within 2 weeks before the first dose of randomised study medication or continue to need these drugs for concurrent therapy: theophylline, bismuth salts, warfarin, phenytoin, tracolimus, diazepam, cyclosporine, disulfiram, benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate clopidogrel or protease inhibitors. 13. Taking concomitant medications that rely on the presence of gastricacid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts). 14. Onset of psychiatric 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 or higher 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 their e-diary. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter is the time to sustained response, which is defined as a reduction of 3 or more points on the 9-point Likert severity scale which is sustained for 45 minutes or more. This will be defined using the median heartburn severity at each time point. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 22 |