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

NCT ID: NCT02670642

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 877 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2002-11-30

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

On demand 20 mg esomeprazole

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

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

Proton pump inhibitor

Continuous 20 mg esomeprazole

Continuous treatment with 20 mg esomeprazole once daily

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

Proton pump inhibitor

Interventions

Esomeprazole

Proton pump inhibitor

Intervention Type: DRUG

Other Intervention Names

Nexium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekkehard Bayerdörffer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl-Gustav-Carus, Medical Clinic and Policlinic I, Fetscherstr. 74, 01307 Dresden, Germany

Locations

A.ö.Landeskrankenhaus Feldbach

Feldbach, , Austria

A.ö. Landeskrankenhaus Kittsee

Kittsee, , Austria

Spitalverbund Landeskrankenhaus

Knittelfeld, , Austria

Krankenhaus der Stadt Wien

Vienna, , Austria

Hanusch Hospital

Vienna, , Austria

A.ö. Krankenhaus Zell am See

Zell am See, , Austria

36 boulevard Gambetta

Alès, , France

84 rue Gustave Colin

Arras, , France

15 rue Michelet

Belfort, , France

30 boulevard du Président John Kennedy

Béziers, , France

10 avenue Villeneuve

Cagnes-sur-Mer, , France

13 rue Roquebillière

Cannes La Bocca, , France

91 rue de Paris

Charenton-le-Pont, , France

62 rue Bonnabaud

Clermont-Ferrand, , France

17 villa du Petit Parc

Créteil, , France

24 quai Saint Maurand

Douai, , France

3 place du Marché Couvert

Dreux, , France

Clinique Saint Vincent

Épernay, , France

7 rue Parmentier

Épinal, , France

Place du Postillon

Issoire, , France

60 rue Jean Bart

Lille, , France

81 avenue du Teil

Montélimar, , France

9 square de Liège

Nancy, , France

6 avenue du Maréchal Juin

Narbonne, , France

74 avenue Paul Doumer

Paris, , France

45bis rue d.Elbeuf

Rouen, , France

64 boulevard Marcel Sembat

Saint-Denis, , France

31 rue Henri Maréchal

Saint-Priest, , France

201 boulevard Robespierre

Talence, , France

4 rue Berlioz

Vélizy-Villacoublay, , France

20 rue de la Glacière

Vitry-sur-Seine, , France

68 avenue Paul Vaillant Couturier

Vitry-sur-Seine, , France

Wartburgstraße 19

Berlin, , Germany

Gemeinschaftspraxis

Cologne, , Germany

Genovevastraße 5

Cologne, , Germany

Carl Gustav Carus der Tecnischen Universität

Dresden, , Germany

Finkenstraße 31

Freising, , Germany

Reichenbacher Str. 106 a

Görlitz, , Germany

Frankenwaldklinik

Kronach, , Germany

Buchentorstr. 16

Lienen, , Germany

Hammer Str. 108

Münster, , Germany

Albersloher Weg 455

Münster, , Germany

Am Bahnhof 3

Oelde, , Germany

Rudolf-Breitscheid-Str. 56

Potsdam, , Germany

Musikantenweg 3

Ribnitz, , Germany

Friedensstr. 14

Wolmirstedt, , 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, , Spain

Hospital General de Guadalajara

Guadalajara, , Spain

Hospital Central de Asturias

Oviedo, , Spain

Hospital Clínico Universitario

Santiago de Compostela, , Spain

Hospital Virgen Macarena

Seville, , Spain

Countries

Austria; France; Germany; South Africa; Spain

References

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.

Reference Type: DERIVED

PMID: 27080034 (View on PubMed)

Other Identifiers

D9612C00004

Identifier Type: -

Identifier Source: org_study_id