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Gastroesophageal RefluxPhase 3NEEDNCT02670642

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

A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux, run by AstraZeneca at 60 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Esomeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
877 participants
Where
60 sitesin 5 countries
Study dates
Aug 2001to Nov 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 35Show fewer
  • 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

Trial locations and contacts

60 sites in 5 countries.

60 sites in 5 countries

France26 sites

  • 36 boulevard Gambetta

    Alès, 30100

  • 84 rue Gustave Colin

    Arras, 62000

  • 15 rue Michelet

    Belfort, 90000

  • 30 boulevard du Président John Kennedy

    Béziers, 34500

  • 10 avenue Villeneuve

    Cagnes-sur-Mer, 06800

  • 13 rue Roquebillière

    Cannes La Bocca, 06150

  • 91 rue de Paris

    Charenton-le-Pont, 94220

  • 62 rue Bonnabaud

    Clermont-Ferrand, 63000

  • 17 villa du Petit Parc

    Créteil, 94000

  • 24 quai Saint Maurand

    Douai, 59500

  • 3 place du Marché Couvert

    Dreux, 28100

  • Clinique Saint Vincent

    Épernay, 51205

  • 7 rue Parmentier

    Épinal, 88000

  • Place du Postillon

    Issoire, 63500

  • 60 rue Jean Bart

    Lille, 59000

  • 81 avenue du Teil

    Montélimar, 26200

  • 9 square de Liège

    Nancy, 54500

  • 6 avenue du Maréchal Juin

    Narbonne, 11100

  • 74 avenue Paul Doumer

    Paris, 75016

  • 45bis rue d.Elbeuf

    Rouen, 76000

  • 64 boulevard Marcel Sembat

    Saint-Denis, 93200

  • 31 rue Henri Maréchal

    Saint-Priest, 69800

  • 201 boulevard Robespierre

    Talence, 33401

  • 4 rue Berlioz

    Vélizy-Villacoublay, 78140

  • 20 rue de la Glacière

    Vitry-sur-Seine, 94400

  • 68 avenue Paul Vaillant Couturier

    Vitry-sur-Seine, 94400

Other trials in France

Germany14 sites

  • Wartburgstraße 19

    Berlin, 10825

  • Gemeinschaftspraxis

    Cologne, 51065

  • Genovevastraße 5

    Cologne, 51065

  • Carl Gustav Carus der Tecnischen Universität

    Dresden, D-010307

  • Finkenstraße 31

    Freising, 85356

  • Reichenbacher Str. 106 a

    Görlitz, 02827

  • Frankenwaldklinik

    Kronach, 96317

  • Buchentorstr. 16

    Lienen, 49536

  • Hammer Str. 108

    Münster, 48153

  • Albersloher Weg 455

    Münster, 48167

  • Am Bahnhof 3

    Oelde, 59302

  • Rudolf-Breitscheid-Str. 56

    Potsdam, 14482

  • Musikantenweg 3

    Ribnitz, 18311

  • Friedensstr. 14

    Wolmirstedt, 39326

Other trials in Germany

South Africa9 sites

  • Gastroenterology Clinic, G73, Department of Internal Medicine, Universitas Hospital

    Bloemfontein

  • Burnside House, Room 1

    Cape Town

  • Gastroenterology Clinic, E23, Groote Schuur Hospital Observatory

    Cape Town

  • Gastroenterology Clinic, Parorama Medi-Clinic

    Cape Town

  • Gastroenterology Unit, Room C78, Tygerberg Hospital

    Cape Town

  • Unitas Hospital Lyttleton

    Centurion

  • Gastroenterology Clinic, Parklands Medical Centre

    Durban

  • Gastroenterology Clinic, Milpark Hospital

    Johannesburg

  • Gastroenterology Unit, Chris Hani Baragwanath Hospital

    Johannesburg

Other trials in South Africa

Austria6 sites

  • A.ö.Landeskrankenhaus Feldbach

    Feldbach, A-8330

  • A.ö. Landeskrankenhaus Kittsee

    Kittsee, A-2421

  • Spitalverbund Landeskrankenhaus

    Knittelfeld, A-8720

  • Krankenhaus der Stadt Wien

    Vienna, A-1030

  • Hanusch Hospital

    Vienna, A-1140

  • A.ö. Krankenhaus Zell am See

    Zell am See, A-5700

Other trials in Austria

Spain5 sites

  • Centro Médico Teknon

    Barcelona, 08022

  • Hospital General de Guadalajara

    Guadalajara, 19009

  • Hospital Central de Asturias

    Oviedo, 33006

  • Hospital Clínico Universitario

    Santiago de Compostela, 15706

  • Hospital Virgen Macarena

    Seville, 41071

Other trials in Spain

About this study

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.

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.

Being tested
Esomeprazole
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsomeprazoleDrug

    Also called Nexium

    Proton pump inhibitor

Study groups in NCT02670642
Study groupRoleWhat they receive
On demand 20 mg esomeprazoleExperimentalOn demand treatment with 20-mg esomeprazole once daily when needed
Receives: Drug: Esomeprazole
Continuous 20 mg esomeprazoleActive comparatorContinuous treatment with 20 mg esomeprazole once daily
Receives: Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (7)

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

    Measured: 6 months

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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 6 months

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

    Measured: 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study startAug 2001
  3. Primary completionNov 2002
  4. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670642
Sponsor's protocol ID
D9612C00004
Acronym
NEED
Status last verified
Jan 2016
First submitted
11 Dec 2015
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27080034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux, run by AstraZeneca at 60 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in France, Germany, South Africa, Austria, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.

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