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

Gastroesophageal Reflux Clinical Trial

— NEED  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670642
• Other study ID #: D9612C00004
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2015
• Last updated: January 28, 2016
• Start date: August 2001
• Est. completion date: November 2002

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilSpain: Agencia Espanola de MedicamentosFrance: Agence National de Sécurité du Medicaments et des produits de santéGermany: Bundesinstitut fur Arzmittel ond Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor

Locations

Country	Name	City	State
Austria	A.ö.Landeskrankenhaus Feldbach	Feldbach
Austria	A.ö. Landeskrankenhaus Kittsee	Kittsee
Austria	Spitalverbund Landeskrankenhaus	Knittelfeld
Austria	Hanusch Hospital	Wien
Austria	Krankenhaus der Stadt Wien	Wien
Austria	A.ö. Krankenhaus Zell am See	Zell am See
France	36 boulevard Gambetta	Ales
France	84 rue Gustave Colin	Arras
France	15 rue Michelet	Belfort
France	30 boulevard du Président John Kennedy	Beziers
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	Creteil
France	24 quai Saint Maurand	Douai
France	3 place du Marché Couvert	Dreux
France	Clinique Saint Vincent	Epernay
France	7 rue Parmentier	Epinal
France	Place du Postillon	Issoire
France	60 rue Jean Bart	Lille
France	81 avenue du Teil	Montelimar
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	Velizy Villacoublay
France	20 rue de la Glacière	Vitry Sur Seine
France	68 avenue Paul Vaillant Couturier	Vitry Sur Seine
Germany	Wartburgstraße 19	Berlin
Germany	Carl Gustav Carus der Tecnischen Universität	Dresden
Germany	Finkenstraße 31	Freising
Germany	Reichenbacher Str. 106 a	Görlitz
Germany	Gemeinschaftspraxis	Köln
Germany	Genovevastraße 5	Köln
Germany	Frankenwaldklinik	Kronach
Germany	Buchentorstr. 16	Lienen
Germany	Albersloher Weg 455	Münster
Germany	Hammer Str. 108	Münster
Germany	Am Bahnhof 3	Oelde
Germany	Rudolf-Breitscheid-Str. 56	Potsdam
Germany	Musikantenweg 3	Ribnitz
Germany	Friedensstr. 14	Wolmirstedt
South Africa	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
Spain	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	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  France,  Germany,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reasons for discontinuation of on-demand or continuous esomeprazole treatment assessed by investigator-completed questionnaire at clinical visits		6 months	No
Secondary	Mean number of esomeprazole tablets taken measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded)		6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Individual patterns of esomeprazole tablet usage measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded)		6 months	No
Secondary	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	No