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AzTrials

Gastroesophageal RefluxPhase 3NCT00163306

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Takeda at 79 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. 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?
Pantoprazole
How many people
1,200 participants
Where
79 sitesin 4 countries
Study dates
May 2005to not given
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

Main Inclusion Criteria:

  • Outpatients
  • Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification

Main Exclusion Criteria:

  • Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on >3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day
  • Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study
  • Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start
  • Eradication of H. pylori during the last 28 days prior to study start
  • Acute peptic ulcer and/or ulcer complications

Trial locations and contacts

79 sites in 4 countries.

79 sites in 4 countries

Germany41 sites

  • Altana Pharma/Nycomed

    Amberg, 92224

  • Altana Pharma/Nycomed

    Aschersleben, 6449

  • Altana Pharma/Nycomed

    Bad Bramstedt, 24576

  • Altana Pharma/Nycomed

    Bad Schwalbach, 65307

  • Altana Pharma/Nycomed

    Beckum, 59269

  • Altana Pharma/Nycomed

    Berlin, 10409

  • Altana Pharma/Nycomed

    Berlin, 12587

  • Altana Pharma/Nycomed

    Berlin, 13581

  • Altana Pharma/Nycomed

    Flensburg, 24937

  • Altana Pharma/Nycomed

    Freiburg im Breisgau, 79098

  • Altana Pharma/Nycomed

    Freising, 85356

  • Altana Pharma/Nycomed

    Germersheim, 76726

  • Altana Pharma/Nycomed

    Hamburg, 22335

  • Altana Pharma/Nycomed

    Haßfurt, 97437

  • Altana Pharma/Nycomed

    Herzogenrath, 52134

  • Altana Pharma/Nycomed

    Jülich, 52428

  • Altana Pharma/Nycomed

    Kirchheimbolanden, 67292

  • Altana Pharma/Nycomed

    Landsberg, 6188

  • Altana Pharma/Nycomed

    Langen, 63225

  • Altana Pharma/Nycomed

    Leipzig, 4105

  • Altana Pharma/Nycomed

    Lübeck, 23569

  • Altana Pharma/Nycomed

    Ludwigsburg, 71640

  • Altana Pharma/Nycomed

    Ludwigshafen, 67067

  • Altana Pharma/Nycomed

    Lütjenburg, 24321

  • Altana Pharma/Nycomed

    Magdeburg, 39114

  • Altana Pharma/Nycomed

    Magdeburg, 39130

  • Altana Pharma/Nycomed

    Mönchengladbach, 41239

  • Altana Pharma/Nycomed

    München, 80337

  • Altana Pharma/Nycomed

    München, 81669

  • Altana Pharma/Nycomed

    Nieder-Olm, 55268

  • Altana Pharma/Nycomed

    Oelde, 59302

  • Altana Pharma/Nycomed

    Potsdam-Babelsberg, 14482

  • Altana Pharma/Nycomed

    Reinfeld, 23858

  • Altana Pharma/Nycomed

    Rottweil, 78628

  • Altana Pharma/Nycomed

    Saarbrücken, 66111

  • Altana Pharma/Nycomed

    Schweinfurt, 97421

  • Altana Pharma/Nycomed

    Stuttgart, 70565

  • Altana Pharma/Nycomed

    Tessin, 18195

  • Altana Pharma/Nycomed

    Wiesbaden, 65189

  • Altana Pharma/Nycomed

    Wolfsburg, 38448

  • Altana Pharma/Nycomed

    Wolmirstedt, 39326

Other trials in Germany

Hungary17 sites

  • Altana Pharma/Nycomed

    Budapest, 1032

  • Altana Pharma/Nycomed

    Budapest, 1062

  • Altana Pharma/Nycomed

    Budapest, 1085

  • Altana Pharma/Nycomed

    Budapest, 1115

  • Altana Pharma/Nycomed

    Győr, 9024

  • Altana Pharma/Nycomed

    Gyula, 5700

  • Altana Pharma/Nycomed

    Hatvan, 3000

  • Altana Pharma/Nycomed

    Kaposvár, 7400

  • Altana Pharma/Nycomed

    Miskolc, 3526

  • Altana Pharma/Nycomed

    Pécs, 7632

  • Altana Pharma/Nycomed

    Szeged, 6720

  • Altana Pharma/Nycomed

    Székesfehérvár, 8000

  • Altana Pharma/Nycomed

    Szekszárd, 7100

  • Altana Pharma/Nycomed

    Szentes, 6600

  • Altana Pharma/Nycomed

    Szombathely, 9701

  • Altana Pharma/Nycomed

    Tatabánya, 2800

  • Altana Pharma/Nycomed

    Vác, 2601

Other trials in Hungary

Austria11 sites

  • Altana Pharma/Nycomed

    Deutschlandsberg, 8539

  • Altana Pharma/Nycomed

    Feldbach, 8330

  • Altana Pharma/Nycomed

    Graz, 8010

  • Altana Pharma/Nycomed

    Graz, 8020

  • Altana Pharma/Nycomed

    Krems A. D. Donau, 3500

  • Altana Pharma/Nycomed

    Lilienfeld, 3180

  • Altana Pharma/Nycomed

    Stockerau, 2000

  • Altana Pharma/Nycomed

    Vienna, 1130

  • Altana Pharma/Nycomed

    Vienna, 1140

  • Altana Pharma/Nycomed

    Vienna, 1170

  • Altana Pharma/Nycomed

    Wiener Neustadt, 2700

Other trials in Austria

Poland10 sites

  • Altana Pharma/Nycomed

    Bydgoszcz, 85-168

  • Altana Pharma/Nycomed

    Drezdenko, 66-530

  • Altana Pharma/Nycomed

    Kielce, 25-513

  • Altana Pharma/Nycomed

    Krakow, 31-153

  • Altana Pharma/Nycomed

    Rzeszów, 35-068

  • Altana Pharma/Nycomed

    Rzeszów, 35025

  • Altana Pharma/Nycomed

    Słupsk, 76200

  • Altana Pharma/Nycomed

    Sopot, 81-756

  • Altana Pharma/Nycomed

    Torun, 87-100

  • Altana Pharma/Nycomed

    Tychy, 43-100

Other trials in Poland

About this study

Official title: Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination).

The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Being tested
Pantoprazole
Keywords
Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • PantoprazoleDrug

What is being measured

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

  1. complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.

Secondary outcomes (11)

  1. complete reflux disease remission rates after 4, 8, and 12 weeks

  2. time to reach first complete remission

  3. time to reach sustained complete remission

  4. time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire

  5. average symptom load above pre-defined GERD symptoms threshold

  6. relief rates from reflux disease related complaints after 4, 8 and 12 weeks

  7. endoscopically confirmed healing rates after 4, 8, and 12 weeks

  8. symptom relief rates after 4, 8 and 12 weeks

  9. influence of the H. pylori status on the complete reflux disease remission rate

  10. influence of the H. pylori status on the symptom relief rates

  11. influence of the H. pylori status on the endoscopically confirmed healing rates.

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startMay 2005

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00163306
Sponsor's protocol ID
BY1023/M3-339
Status last verified
May 2007
First submitted
12 Sep 2005
Last updated
7 May 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Takeda at 79 sites in 4 countries.

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

Who may be eligible to take part?

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 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany, Hungary, Austria, Poland. 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?

complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.. 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 NCT00163306.

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 7 May 2012.

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