E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastroesophageal Reflux Disease (GERD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017885 |
E.1.2 | Term | Gastrooesophageal reflux disease |
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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 |
To compare the clinical outcome (control of symptoms of GERD) in patients treated by PCPs who implemented the structured pathway (Implementation Group) with the clinical outcome of patients treated by PCPs who follow clinical practice without implementing the structured pathway (Control Group). |
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E.2.2 | Secondary objectives of the trial |
To compare the direct healthcare resources consumption during the study of Implementation Group vs Control Group. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Signed and dated informed consent will be obtained before any study related procedure is conducted. 2.Male or female aged ≥ 18years. 3.Patients presenting with symptoms suggestive of typical GERD (heartburn or regurgitation as prevailing symptoms) of any severity and frequency: a.New diagnosis or symptom relapse b.No treatment with PPIs or H2 antagonists or a maximum of two doses a week in the past two weeks, allowing treatment with antacids. 4.Patient able to understand and complete the questionnaire. |
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E.4 | Principal exclusion criteria |
1.Documented medical history or gastrointestinal pathology such as: -Gastrointestinal malignancy -Zollinger-Ellison syndrome; malabsorption -Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the Investigator to interfere with the evaluation of the study -Unstable diabetes mellitus as judged by the Investigator to interfere with the evaluation of the study. 2.Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: Previous lower gastrointestinal surgery such as appendectomy, colonic resection, cholecystectomy, or gynaecological surgery are not exclusion criteria. 3.Presence of Irritable Bowel Syndrome. This is characterised by chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to the irritable bowel syndrome or two or more of the following criteria. -Visible abdominal distension -Pain relieved by a bowel action -More frequent stools with the onset of pain -Looser stools with onset of pain -Rectal passage of mucus -A sensation of incomplete defecation 4.Presence of any alarm symptoms suggestive of organic disease, including but not limited to, vomiting, GI bleeding or anaemia, abdominal mass, unexplained weight loss and dysphagia. 5.Severe, concurrent mental illness that may complicate the study evaluation or affect subject compliance as judged by the Investigator. 6.Requirement for continuous concurrent therapy with the following medications during the study period: -sucralrate -quinidine -warfarin and other vitamin K antagonists -phenytoin -biphosphonates -methotrexate -antidepressants (therapy less than 3 days per week is acceptable) -prostaglandin analogues such as misoprostol -ketoconazole, fluconazole, itraconazole -diazepam -cisapride -NSAIDs -aspirin >300mg/day 7.Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test and maintain contraception during the study medication treatment period. Investigators should be satisfied that those women who are not surgically sterilized or are < 1 year post-menopausal are not pregnant at study entry. 8.Chronic alcoholism, drug abuse, or psychological condition judged by the PCP to potentially result in poor subject compliance or interfere with study evaluation. 9.Suspected or confirmed current malignancy except basal cell carcinoma. Current is defined as: any malignancy, expect basal cell carcinoma, that has been active within the previous 12 months. 10.Known hypersensitivity to PPIs or any of their constituents. 11.Participation in a clinical study during the last 90 days. |
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
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 | 7 |