A randomized, open, parallel-group, multi-centre, phase IV study toevaluate the efficacy of three different patient management strategies withand without esomeprazole 20 mg during a 3 months maintenance phasefollowing an initial 4-weeks acute treatment phase in subjects withsymptoms thought to be GERD related - SYMPATHY

• Conditions: Symptoms thought to be gastroesophageal reflux disease (GERD)-related

• Registration Number: EUCTR2006-001316-76-DE
• Lead Sponsor: AstraZeneca GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7600

Inclusion Criteria

1. Signed informed consent from the subject prior to conducting any study-related procedures.
2. Males or females aged between 18 and 50 years.
3. Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
4. Subjects should be eligible for empirical treatment for up to 16 weeks with either esomeprazole and / or rescue medication (antacids) according to physician’s judgement.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with any clinical GERD diagnosis / treatment (PPI, H2-receptor antagonists) within last 3 months prior to Visit 1.
2. Subjects with a history of severe esophagitis (i.e. LA grade C or D) or known other complications (e.g. Barrett‘s esophagus, stricture).
3. Previous anti-reflux surgery, or any form of upper gastrointestinal resective surgery.
4. Subjects with alarm symptoms such as unintentional weight loss, dysphagia, disturbed food passage, persistent vomiting, haematemesis, melena and jaundice.
5. Any other signs / suspicions indicating serious or malignant disease.
6. Subjects with dominant symptoms suggestive of peptic ulcer disease or dyspepsia (functional dyspepsia is defined as persistent or recurrent pain or discomfort centred in the upper abdomen [Rome II criteria]).
7. Subjects with 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 irritable bowel syndrome, or two or more of the following criteria:
- visible abdominal distention,
- pain relieved by a bowel action,
- more frequent stools with the onset of pain,
- looser stools with the onset of pain,
- rectal passage of mucus,
- a sensation of incomplete defecation.
8. Any significant past or current disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study or subject’s ability to participate in the study.
9. Subjects with a need for a NSAID therapy or an ASA therapy with a daily dose > 325 mg.
10. Subject judged by investigator not to be capable to understand and complete PRO Questionnaires reliably.
11. Subjects taking contraindicated concomitant medication according to local Market Data Sheet (MDS).
12. Pregnancy or lactation. Women of childbearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy. Acceptable methods include implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or sterilisation (including vasectomy).
13. Subjects with a known hypersensitivity to any component of esomeprazole or rescue medication used in the study.
14. Planned donation of blood during the study participation.
15. Planned hospitalization during the study participation.
16. History of alcohol or drug abuse in the last two years or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator.
17. Participation in another clinical study of any investigational drug within 30 days prior to start or during the course of the study.
18. Previous enrolment in this study.
19. Involvement in the planning and conduct of the study (applies to both, AstraZeneca staff or staff at the study site).

Study & Design

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