Evaluation Study of a New Management Strategy for Gastroesophageal Reflux Disease (GERD) - GMP

• Conditions: Gastroesophageal Reflux Disease (GERD); MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2008-006742-26-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: To compare the direct healthcare resources consumption during the study of Implementation Group vs Control Group.;Primary end point(s):