MedDataX Logo

Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders

NCT ID: NCT00830115

Last Updated: 2012-05-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1045 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

NCT00561730

Gastroesophageal Reflux Disease
COMPLETED

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

NCT00326027

Gastroesophageal Reflux
COMPLETED PHASE3

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

NCT00163306

Gastroesophageal Reflux
COMPLETED PHASE3

Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

NCT00287391

Insomnia GERD
COMPLETED PHASE4

Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.

NCT00674245

Gastroesophageal Reflux Disease
COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Disorders Non-Erosive Reflux Disease Gastroesophageal Reflux Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pantoprazole

All patients enrolled

Pantoprazole

Intervention Type DRUG

Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pantoprazole

Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

Exclusion Criteria

* Criteria as defined in the respective Summary of Product Characteristics (Chapter 4.3)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nycomed

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nycomed Deutschland GmbH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Bethke, MD, MBA

Role: STUDY_DIRECTOR

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nycomed Deutschland GmbH

Aachen, , Germany

Site Status

Nycomed Deutschland GmbH

Ahrensburg, , Germany

Site Status

Nycomed Deutschland GmbH

Altenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Ansbach, , Germany

Site Status

Nycomed Deutschland GmbH

Aschaffenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Augsburg, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Bederkesa, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Doberan, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Essen, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Kissigen, , Germany

Site Status

Nycomed Deutschland GmbH

Bassum, , Germany

Site Status

Nycomed Deutschland GmbH

Beckum-Neubeckum, , Germany

Site Status

Nycomed Deutschland GmbH

Bergkamen, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Bietigheim, , Germany

Site Status

Nycomed Deutschland GmbH

Bitterfeld-Wolfen, , Germany

Site Status

Nycomed Deutschland GmbH

Bochum, , Germany

Site Status

Nycomed Deutschland GmbH

Bochum, , Germany

Site Status

Nycomed Deutschland GmbH

Bodenwerder, , Germany

Site Status

Nycomed Deutschland GmbH

Bovenden, , Germany

Site Status

Nycomed Deutschland GmbH

Bramsche, , Germany

Site Status

Nycomed Deutschland GmbH

Brandenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Bredstedt, , Germany

Site Status

Nycomed Deutschland GmbH

Bremen, , Germany

Site Status

Nycomed Deutschland GmbH

Bremen, , Germany

Site Status

Nycomed Deutschland GmbH

Bremerhaven, , Germany

Site Status

Nycomed Deutschland GmbH

Butzbach, , Germany

Site Status

Nycomed Deutschland GmbH

Castrop-Rauxel, , Germany

Site Status

Nycomed Deutschland GmbH

Chemnitz, , Germany

Site Status

Nycomed Deutschland GmbH

Chemnitz, , Germany

Site Status

Nycomed Deutschland GmbH

Chemnitz, , Germany

Site Status

Nycomed Deutschland GmbH

Clenze, , Germany

Site Status

Nycomed Deutschland GmbH

Coburg, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cottbus, , Germany

Site Status

Nycomed Deutschland GmbH

Cottbus, , Germany

Site Status

Nycomed Deutschland GmbH

Cölbe, , Germany

Site Status

Nycomed Deutschland GmbH

Crailsheim, , Germany

Site Status

Nycomed Deutschland GmbH

Darmstadt, , Germany

Site Status

Nycomed Deutschland GmbH

Deggendorf, , Germany

Site Status

Nycomed Deutschland GmbH

Dessau, , Germany

Site Status

Nycomed Deutschland GmbH

Dinkelsbühl, , Germany

Site Status

Nycomed Deutschland GmbH

Dippoldswalde, , Germany

Site Status

Nycomed Deutschland GmbH

Dortmund, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Eisenach, , Germany

Site Status

Nycomed Deutschland GmbH

Ellefeld, , Germany

Site Status

Nycomed Deutschland GmbH

Erfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Erlenbach, , Germany

Site Status

Nycomed Deutschland GmbH

Eschweiler, , Germany

Site Status

Nycomed Deutschland GmbH

Essen, , Germany

Site Status

Nycomed Deutschland GmbH

Essen, , Germany

Site Status

Nycomed Deutschland GmbH

Esslingen am Neckar, , Germany

Site Status

Nycomed Deutschland GmbH

Flensburg, , Germany

Site Status

Nycomed Deutschland GmbH

Frankfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Freiburg im Breisgau, , Germany

Site Status

Nycomed Deutschland GmbH

Freising, , Germany

Site Status

Nycomed Deutschland GmbH

Freudenstadt, , Germany

Site Status

Nycomed Deutschland GmbH

Fürstenzell, , Germany

Site Status

Nycomed Deutschland GmbH

Fürth, , Germany

Site Status

Nycomed Deutschland GmbH

Gardelegen, , Germany

Site Status

Nycomed Deutschland GmbH

Gera, , Germany

Site Status

Nycomed Deutschland GmbH

Gera, , Germany

Site Status

Nycomed Deutschland GmbH

Goch, , Germany

Site Status

Nycomed Deutschland GmbH

Goslar, , Germany

Site Status

Nycomed Deutschland GmbH

Greifsfeld, , Germany

Site Status

Nycomed Deutschland GmbH

Greifswald, , Germany

Site Status

Nycomed Deutschland GmbH

Grevenbroich, , Germany

Site Status

Nycomed Deutschland GmbH

Grimmen, , Germany

Site Status

Nycomed Deutschland GmbH

Großaitingen, , Germany

Site Status

Nycomed Deutschland GmbH

Güstrow, , Germany

Site Status

Nycomed Deutschland GmbH

Halberstadt, , Germany

Site Status

Nycomed Deutschland GmbH

Halle, , Germany

Site Status

Nycomed Deutschland GmbH

Hamburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hamburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hamburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Harra, , Germany

Site Status

Nycomed Deutschland GmbH

Haßfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Haßloch, , Germany

Site Status

Nycomed Deutschland GmbH

Hechingen, , Germany

Site Status

Nycomed Deutschland GmbH

Heide, , Germany

Site Status

Nycomed Deutschland GmbH

Henstedt-Ulzburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hildesheim, , Germany

Site Status

Nycomed Deutschland GmbH

Hof, , Germany

Site Status

Nycomed Deutschland GmbH

Holzgerlingen, , Germany

Site Status

Nycomed Deutschland GmbH

Ibbenbueren, , Germany

Site Status

Nycomed Deutschland GmbH

Johanngeorgenstadt, , Germany

Site Status

Nycomed Deutschland GmbH

Karlstadt am Main, , Germany

Site Status

Nycomed Deutschland GmbH

Kassel, , Germany

Site Status

Nycomed Deutschland GmbH

Kelkheim, , Germany

Site Status

Nycomed Deutschland GmbH

Kiel, , Germany

Site Status

Nycomed Deutschland GmbH

Koblenz, , Germany

Site Status

Nycomed Deutschland GmbH

Kornwestheim, , Germany

Site Status

Nycomed Deutschland GmbH

L.-E.-Musberg, , Germany

Site Status

Nycomed Deutschland GmbH

Landstuhl, , Germany

Site Status

Nycomed Deutschland GmbH

Leer, , Germany

Site Status

Nycomed Deutschland GmbH

Leipzig, , Germany

Site Status

Nycomed Deutschland GmbH

Leipzig, , Germany

Site Status

Nycomed Deutschland GmbH

Leipzig, , Germany

Site Status

Nycomed Deutschland GmbH

Leverkusen, , Germany

Site Status

Nycomed Deutschland GmbH

Lichtenfels, , Germany

Site Status

Nycomed Deutschland GmbH

Limburg, , Germany

Site Status

Nycomed Deutschland GmbH

Lingen, , Germany

Site Status

Nycomed Deutschland GmbH

Ludwigsfelde, , Germany

Site Status

Nycomed Deutschland GmbH

Ludwigshafen, , Germany

Site Status

Nycomed Deutschland GmbH

Ludwigshaven-Oggersheim, , Germany

Site Status

Nycomed Deutschland GmbH

Lübeck, , Germany

Site Status

Nycomed Deutschland GmbH

Lüdenscheid, , Germany

Site Status

Nycomed Deutschland GmbH

Magdeburg, , Germany

Site Status

Nycomed Deutschland GmbH

Mainz, , Germany

Site Status

Nycomed Deutschland GmbH

Mannheim, , Germany

Site Status

Nycomed Deutschland GmbH

Mannheim, , Germany

Site Status

Nycomed Deutschland GmbH

Marienberg, , Germany

Site Status

Nycomed Deutschland GmbH

Marl, , Germany

Site Status

Nycomed Deutschland GmbH

Merseburg, , Germany

Site Status

Nycomed Deutschland GmbH

Merzig-Schwemlingen, , Germany

Site Status

Nycomed Deutschland GmbH

Mettlach, , Germany

Site Status

Nycomed Deutschland GmbH

Minden, , Germany

Site Status

Nycomed Deutschland GmbH

Minden, , Germany

Site Status

Nycomed Deutschland GmbH

Möckmühl, , Germany

Site Status

Nycomed Deutschland GmbH

Mönchnegladbach, , Germany

Site Status

Nycomed Deutschland GmbH

München, , Germany

Site Status

Nycomed Deutschland GmbH

München, , Germany

Site Status

Nycomed Deutschland GmbH

München, , Germany

Site Status

Nycomed Deutschland GmbH

Münzenberg, , Germany

Site Status

Nycomed Deutschland GmbH

Neckargemünd, , Germany

Site Status

Nycomed Deutschland GmbH

Neu Wulmstorf, , Germany

Site Status

Nycomed Deutschland GmbH

Neu-Isenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Neukirchen, , Germany

Site Status

Nycomed Deutschland GmbH

Neuruppin, , Germany

Site Status

Nycomed Deutschland GmbH

Neustadt an der Orla, , Germany

Site Status

Nycomed Deutschland GmbH

Neustadt in Sachsen, , Germany

Site Status

Nycomed Deutschland GmbH

Nieder-Olm, , Germany

Site Status

Nycomed Deutschland GmbH

Nordhausen, , Germany

Site Status

Nycomed Deutschland GmbH

Oberhausen, , Germany

Site Status

Nycomed Deutschland GmbH

Oberndorf, , Germany

Site Status

Nycomed Deutschland GmbH

Ochsenfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Oelsnitz/Erzgeb., , Germany

Site Status

Nycomed Deutschland GmbH

Oldenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Paderborn, , Germany

Site Status

Nycomed Deutschland GmbH

Papenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Penig, , Germany

Site Status

Nycomed Deutschland GmbH

Plauen, , Germany

Site Status

Nycomed Deutschland GmbH

Plettenberg, , Germany

Site Status

Nycomed Deutschland GmbH

Potsdam, , Germany

Site Status

Nycomed Deutschland GmbH

Potsdam, , Germany

Site Status

Nycomed Deutschland GmbH

Potsdam, , Germany

Site Status

Nycomed Deutschland GmbH

Recklinghausen, , Germany

Site Status

Nycomed Deutschland GmbH

Regensburg, , Germany

Site Status

Nycomed Deutschland GmbH

Remscheid, , Germany

Site Status

Nycomed Deutschland GmbH

Riesa, , Germany

Site Status

Nycomed Deutschland GmbH

Rostock, , Germany

Site Status

Nycomed Deutschland GmbH

Rottach, , Germany

Site Status

Nycomed Deutschland GmbH

Rottweil, , Germany

Site Status

Nycomed Deutschland GmbH

Saarbrücken, , Germany

Site Status

Nycomed Deutschland GmbH

Saarlouis, , Germany

Site Status

Nycomed Deutschland GmbH

Saint Blasien, , Germany

Site Status

Nycomed Deutschland GmbH

Salzgitter, , Germany

Site Status

Nycomed Deutschland GmbH

Schiffweiler, , Germany

Site Status

Nycomed Deutschland GmbH

Schmalkalden, , Germany

Site Status

Nycomed Deutschland GmbH

Schwarmstedt, , Germany

Site Status

Nycomed Deutschland GmbH

Schwäbisch Hall, , Germany

Site Status

Nycomed Deutschland GmbH

Schwerin, , Germany

Site Status

Nycomed Deutschland GmbH

Sondeshausen, , Germany

Site Status

Nycomed Deutschland GmbH

Spaichingen, , Germany

Site Status

Nycomed Deutschland GmbH

Steinfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Steißlingen, , Germany

Site Status

Nycomed Deutschland GmbH

Stockach, , Germany

Site Status

Nycomed Deutschland GmbH

Strausberg, , Germany

Site Status

Nycomed Deutschland GmbH

Sundern, , Germany

Site Status

Nycomed Deutschland GmbH

Tapfheim, , Germany

Site Status

Nycomed Deutschland GmbH

Varel, , Germany

Site Status

Nycomed Deutschland GmbH

Waghäusel, , Germany

Site Status

Nycomed Deutschland GmbH

Wangen, , Germany

Site Status

Nycomed Deutschland GmbH

Wanzleben, , Germany

Site Status

Nycomed Deutschland GmbH

Weißenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Weißenfels, , Germany

Site Status

Nycomed Deutschland GmbH

Wiesbaden, , Germany

Site Status

Nycomed Deutschland GmbH

Willich, , Germany

Site Status

Nycomed Deutschland GmbH

Wismar, , Germany

Site Status

Nycomed Deutschland GmbH

Wittenberg, , Germany

Site Status

Nycomed Deutschland GmbH

Zell, , Germany

Site Status

Nycomed Deutschland GmbH

Zerbst, , Germany

Site Status

Nycomed Deutschland GmbH

Zweibrücken, , Germany

Site Status

Nycomed Deutschland GmbH

Zwickau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P2-9999-010-DE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
NCT01079884 COMPLETED NA
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
NCT01472939 COMPLETED PHASE2
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
NCT03116841 COMPLETED PHASE4
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
NCT00660660 COMPLETED PHASE4
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
NCT00336219 COMPLETED PHASE3
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
NCT00246909 COMPLETED PHASE4
Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients
NCT01797939 COMPLETED
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
NCT00701259 COMPLETED PHASE3
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
NCT01128582 UNKNOWN PHASE3
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
NCT04799158 COMPLETED PHASE2
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
NCT00300755 COMPLETED PHASE3
Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.
NCT00553449 COMPLETED PHASE3
Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients
NCT01065649 COMPLETED PHASE3
Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease
NCT06945237 COMPLETED NA
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
NCT01037452 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
NCT05195528 COMPLETED PHASE3
Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers
NCT03402984 COMPLETED NA
Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
NCT02140073 UNKNOWN PHASE4
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease
NCT00461604 COMPLETED
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
NCT03436914 COMPLETED NA
Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor
NCT03793556 COMPLETED NA
Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
NCT02533349 UNKNOWN PHASE3
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
NCT00394472 COMPLETED PHASE2
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT00365300 COMPLETED PHASE3
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
NCT00389948 COMPLETED PHASE3