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NEED: Open, Randomised, Multi-center Study of on Demand Versus Continuous Esomeprazole Treatment in Patient With GERD

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02670642
Collaborator
(none)
877
Enrollment
60
Locations
2
Arms
15
Duration (Months)
14.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
877 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Nov 1, 2002
Actual Study Completion Date :
Nov 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: On demand 20 mg esomeprazole

On demand treatment with 20-mg esomeprazole once daily when needed

Drug: Esomeprazole
Proton pump inhibitor
Other Names:
  • Nexium

    		•
    Active Comparator: Continuous 20 mg esomeprazole

    Continuous treatment with 20 mg esomeprazole once daily

    Drug: Esomeprazole
    Proton pump inhibitor
    Other Names:
  • Nexium

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [6 months]

      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

    Secondary Outcome Measures

    1. Reasons for discontinuation of on-demand or continuous esomeprazole treatment assessed by investigator-completed questionnaire at clinical visits [6 months]

    2. Mean number of esomeprazole tablets taken measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded) [6 months]

    3. 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]

    4. 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]

    5. 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]

    6. Individual patterns of esomeprazole tablet usage measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded) [6 months]

    7. Change from baseline in impact of reflux symptoms on health-related quality of life using pre-specified dimensions of the Quality Of Life in Reflux And Dyspepsia (QOLRAD) questionnaire [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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)

    • 7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)

    Exclusion Criteria:

    • 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

    • Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable

    • Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus

    • Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy

    • Use of PPIs for more than 5 days in the last 7 days prior to endoscopy

    • Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study

    • Need for continuous concurrent therapy with

    • NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily for cardiovascular prophylaxis)

    • anticholinergics

    • prostaglandin analogues

    • phenytoin

    • ketoconazole

    • itraconazole

    • warfarin and other vitamin K antagonists

    • Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For

    South-Africa and Spain:

    Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)

    • Use of any other investigational compound 28 days prior to start and during the study

    • Requirement of an interpreter (illiterate)

    • Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator

    • Previous participation in this study

    • Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.ö.Landeskrankenhaus Feldbach Feldbach Austria A-8330
    2 A.ö. Landeskrankenhaus Kittsee Kittsee Austria A-2421
    3 Spitalverbund Landeskrankenhaus Knittelfeld Austria A-8720
    4 Krankenhaus der Stadt Wien Wien Austria A-1030
    5 Hanusch Hospital Wien Austria A-1140
    6 A.ö. Krankenhaus Zell am See Zell am See Austria A-5700
    7 36 boulevard Gambetta Ales France 30100
    8 84 rue Gustave Colin Arras France 62000
    9 15 rue Michelet Belfort France 90000
    10 30 boulevard du Président John Kennedy Beziers France 34500
    11 10 avenue Villeneuve Cagnes Sur Mer France 06800
    12 13 rue Roquebillière Cannes La Bocca France 06150
    13 91 rue de Paris Charenton Le Pont France 94220
    14 62 rue Bonnabaud Clermont Ferrand France 63000
    15 17 villa du Petit Parc Creteil France 94000
    16 24 quai Saint Maurand Douai France 59500
    17 3 place du Marché Couvert Dreux France 28100
    18 Clinique Saint Vincent Epernay France 51205
    19 7 rue Parmentier Epinal France 88000
    20 Place du Postillon Issoire France 63500
    21 60 rue Jean Bart Lille France 59000
    22 81 avenue du Teil Montelimar France 26200
    23 9 square de Liège Nancy France 54500
    24 6 avenue du Maréchal Juin Narbonne France 11100
    25 74 avenue Paul Doumer Paris France 75016
    26 45bis rue d.Elbeuf Rouen France 76000
    27 64 boulevard Marcel Sembat Saint Denis France 93200
    28 31 rue Henri Maréchal Saint Priest France 69800
    29 201 boulevard Robespierre Talence France 33401
    30 4 rue Berlioz Velizy Villacoublay France 78140
    31 20 rue de la Glacière Vitry Sur Seine France 94400
    32 68 avenue Paul Vaillant Couturier Vitry Sur Seine France 94400
    33 Wartburgstraße 19 Berlin Germany 10825
    34 Carl Gustav Carus der Tecnischen Universität Dresden Germany D-010307
    35 Finkenstraße 31 Freising Germany 85356
    36 Reichenbacher Str. 106 a Görlitz Germany 02827
    37 Frankenwaldklinik Kronach Germany 96317
    38 Gemeinschaftspraxis Köln Germany 51065
    39 Genovevastraße 5 Köln Germany 51065
    40 Buchentorstr. 16 Lienen Germany 49536
    41 Hammer Str. 108 Münster Germany 48153
    42 Albersloher Weg 455 Münster Germany 48167
    43 Am Bahnhof 3 Oelde Germany 59302
    44 Rudolf-Breitscheid-Str. 56 Potsdam Germany 14482
    45 Musikantenweg 3 Ribnitz Germany 18311
    46 Friedensstr. 14 Wolmirstedt Germany 39326
    47 Gastroenterology Clinic, G73, Department of Internal Medicine, Universitas Hospital Bloemfontein South Africa
    48 Burnside House, Room 1 Cape Town South Africa
    49 Gastroenterology Clinic, E23, Groote Schuur Hospital Observatory Cape Town South Africa
    50 Gastroenterology Clinic, Parorama Medi-Clinic Cape Town South Africa
    51 Gastroenterology Unit, Room C78, Tygerberg Hospital Cape Town South Africa
    52 Unitas Hospital Lyttleton Centurion South Africa
    53 Gastroenterology Clinic, Parklands Medical Centre Durban South Africa
    54 Gastroenterology Clinic, Milpark Hospital Johannesburg South Africa
    55 Gastroenterology Unit, Chris Hani Baragwanath Hospital Johannesburg South Africa
    56 Centro Médico Teknon Barcelona Spain 08022
    57 Hospital General de Guadalajara Guadalajara Spain 19009
    58 Hospital Central de Asturias Oviedo Spain 33006
    59 Hospital Clínico Universitario Santiago de Compostela Spain 15706
    60 Hospital Virgen Macarena Sevilla Spain 41071

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Ekkehard Bayerdörffer, MD, University Hospital Carl-Gustav-Carus, Medical Clinic and Policlinic I, Fetscherstr. 74, 01307 Dresden, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02670642
    Other Study ID Numbers:
    • D9612C00004
    First Posted:
    Feb 2, 2016
    Last Update Posted:
    Feb 2, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esomeprazole

    Study Results

    No Results Posted as of Feb 2, 2016