Open, Randomised, Multi-center Study of on Demand Versus Continuous Esomeprazole Treatment in Patient With GERD
NEED
On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease (GERD) With Esomeprazole 20-mg Once Daily Over a 6 Months Long Term Treatment Phase. An Open, Randomised, Multicenter Study. NEED.
1 other identifier
interventional
877
5 countries
60
Brief Summary
The purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2001
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 11, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedFebruary 2, 2016
January 1, 2016
1.3 years
December 11, 2015
January 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient
Compare on demand (taken as needed by the patient to adequately control their reflux disease) with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief
6 months
Secondary Outcomes (7)
Reasons for discontinuation of on-demand or continuous esomeprazole treatment assessed by investigator-completed questionnaire at clinical visits
6 months
Mean number of esomeprazole tablets taken measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded)
6 months
Change from baseline in impact of reflux symptoms on health-related quality of life using pre-specified dimensions of the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
6 months
Difference between the proportion of patients reporting treatment satisfaction with on-demand versus continuous esomeprazole treatment assessed by standard patient-completed electronic questionnaire at clinical visits and premature discontinuation
6 months
Frequency of adverse events and assessment of hematology (hemoglobin, leukocytes, thrombocytes) and clinical chemistry (creatinine, alkaline phosphate, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, total bilirubin)
6 months
- +2 more secondary outcomes
Study Arms (2)
On demand 20 mg esomeprazole
EXPERIMENTALOn demand treatment with 20-mg esomeprazole once daily when needed
Continuous 20 mg esomeprazole
ACTIVE COMPARATORContinuous treatment with 20 mg esomeprazole once daily
Interventions
Proton pump inhibitor
Eligibility Criteria
You may qualify if:
- Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months.
- Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or, if PPI treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of PPI treatment
- Male or female, at least 18 years of age (for Austria, at least 19 years of age)
- Have given written informed consent
- Ability to read and write (literate)
- symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)
You may not qualify if:
- Documented esophageal mucosal break
- History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer
- 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:
- Symptoms relieved by defecation
- Symptoms associated with change in frequency of stools
- Symptoms associated with change in form of stools
- Any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.
- Subjects with current or historical evidence of the following diseases/conditions
- Zollinger Ellison syndrome
- Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm
- Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus
- Evidence of upper gastrointestinal malignancy at the screening endoscopy
- Gastric and/or duodenal ulcers within the last 2 years
- Malabsorption
- Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
A.ö.Landeskrankenhaus Feldbach
Feldbach, A-8330, Austria
A.ö. Landeskrankenhaus Kittsee
Kittsee, A-2421, Austria
Spitalverbund Landeskrankenhaus
Knittelfeld, A-8720, Austria
Krankenhaus der Stadt Wien
Vienna, A-1030, Austria
Hanusch Hospital
Vienna, A-1140, Austria
A.ö. Krankenhaus Zell am See
Zell am See, A-5700, Austria
36 boulevard Gambetta
Alès, 30100, France
84 rue Gustave Colin
Arras, 62000, France
15 rue Michelet
Belfort, 90000, France
30 boulevard du Président John Kennedy
Béziers, 34500, France
10 avenue Villeneuve
Cagnes-sur-Mer, 06800, France
13 rue Roquebillière
Cannes La Bocca, 06150, France
91 rue de Paris
Charenton-le-Pont, 94220, France
62 rue Bonnabaud
Clermont-Ferrand, 63000, France
17 villa du Petit Parc
Créteil, 94000, France
24 quai Saint Maurand
Douai, 59500, France
3 place du Marché Couvert
Dreux, 28100, France
Clinique Saint Vincent
Épernay, 51205, France
7 rue Parmentier
Épinal, 88000, France
Place du Postillon
Issoire, 63500, France
60 rue Jean Bart
Lille, 59000, France
81 avenue du Teil
Montélimar, 26200, France
9 square de Liège
Nancy, 54500, France
6 avenue du Maréchal Juin
Narbonne, 11100, France
74 avenue Paul Doumer
Paris, 75016, France
45bis rue d.Elbeuf
Rouen, 76000, France
64 boulevard Marcel Sembat
Saint-Denis, 93200, France
31 rue Henri Maréchal
Saint-Priest, 69800, France
201 boulevard Robespierre
Talence, 33401, France
4 rue Berlioz
Vélizy-Villacoublay, 78140, France
20 rue de la Glacière
Vitry-sur-Seine, 94400, France
68 avenue Paul Vaillant Couturier
Vitry-sur-Seine, 94400, France
Wartburgstraße 19
Berlin, 10825, Germany
Gemeinschaftspraxis
Cologne, 51065, Germany
Genovevastraße 5
Cologne, 51065, Germany
Carl Gustav Carus der Tecnischen Universität
Dresden, D-010307, Germany
Finkenstraße 31
Freising, 85356, Germany
Reichenbacher Str. 106 a
Görlitz, 02827, Germany
Frankenwaldklinik
Kronach, 96317, Germany
Buchentorstr. 16
Lienen, 49536, Germany
Hammer Str. 108
Münster, 48153, Germany
Albersloher Weg 455
Münster, 48167, Germany
Am Bahnhof 3
Oelde, 59302, Germany
Rudolf-Breitscheid-Str. 56
Potsdam, 14482, Germany
Musikantenweg 3
Ribnitz, 18311, Germany
Friedensstr. 14
Wolmirstedt, 39326, Germany
Gastroenterology Clinic, G73, Department of Internal Medicine, Universitas Hospital
Bloemfontein, South Africa
Burnside House, Room 1
Cape Town, South Africa
Gastroenterology Clinic, E23, Groote Schuur Hospital Observatory
Cape Town, South Africa
Gastroenterology Clinic, Parorama Medi-Clinic
Cape Town, South Africa
Gastroenterology Unit, Room C78, Tygerberg Hospital
Cape Town, South Africa
Unitas Hospital Lyttleton
Centurion, South Africa
Gastroenterology Clinic, Parklands Medical Centre
Durban, South Africa
Gastroenterology Clinic, Milpark Hospital
Johannesburg, South Africa
Gastroenterology Unit, Chris Hani Baragwanath Hospital
Johannesburg, South Africa
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital General de Guadalajara
Guadalajara, 19009, Spain
Hospital Central de Asturias
Oviedo, 33006, Spain
Hospital Clínico Universitario
Santiago de Compostela, 15706, Spain
Hospital Virgen Macarena
Seville, 41071, Spain
Related Publications (1)
Bayerdorffer E, Bigard MA, Weiss W, Mearin F, Rodrigo L, Dominguez Munoz JE, Grundling H, Persson T, Svedberg LE, Keeling N, Eklund S. Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease. BMC Gastroenterol. 2016 Apr 14;16:48. doi: 10.1186/s12876-016-0448-x.
PMID: 27080034DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekkehard Bayerdörffer, MD
University Hospital Carl-Gustav-Carus, Medical Clinic and Policlinic I, Fetscherstr. 74, 01307 Dresden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2015
First Posted
February 2, 2016
Study Start
August 1, 2001
Primary Completion
November 1, 2002
Study Completion
November 1, 2002
Last Updated
February 2, 2016
Record last verified: 2016-01