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 Phase 3

• 1 other identifier: BY1023/M3-343
• Study Type: interventional
• Target: 628
• Locations: 3 countries
• Sites: 35

Brief Summary

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.

Conditions

GERD

Keywords

GERD; Pantoprazole

Outcome Measures

Primary Outcomes (1)

• symptom assessment as measured by ReQuest™ questionnaire and investigator.

  28 days

Secondary Outcomes (4)

• symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator

  28 days

• endoscopic healing after 28 days

  28 days

• health-related quality of life after 28 days

  28 days

• safety.

  28 days

Study Arms (1)

1

ACTIVE COMPARATOR

Pantoprazole 40 mg

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Symptom Assessment after treatment with Pantoprozole 40 mg

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Outpatients
• Endoscopically confirmed erosive GERD or non-erosive GERD

You may not qualify if:

• Acute peptic ulcer and/or ulcer complications
• PPIs during last 7 days prior to study start
• Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
• Intake of PPIs in combination with antibiotics for eradication of H. pylori

Sponsors & Collaborators

• Takeda: lead

Study Sites (40)

Altana Pharma/Nycomed

Bondi Junction, NSW 2022, Australia

Location

Altana Pharma/Nycomed

Box Hill, Victoria, 3128, Australia

Location

Altana Pharma/Nycomed

New South Wales, 2138, Australia

Location

Altana Pharma/Nycomed

South Australia, 5000, Australia

Location

Altana Pharma/Nycomed

Feldbach, 8330, Austria

Location

Altana Pharma/Nycomed

Graz, 8020, Austria

Location

Altana Pharma/Nycomed

Stockerau, 2000, Austria

Location

Altana Pharma/Nycomed

Vienna, 1140, Austria

Location

Altana Pharma/Nycomed

Wiener Neustadt, 2700, Austria

Location

Altana Pharma/Nycomed

Amberg, 92224, Germany

Location

Altana Pharma/Nycomed

Aschersleben, 6449, Germany

Location

Altana Pharma/Nycomed

Berlin, 10409, Germany

Location

Altana Pharma/Nycomed

Berlin, 12587, Germany

Location

Altana Pharma/Nycomed

Berlin, 13581, Germany

Location

Altana Pharma/Nycomed

Cologne, 50999, Germany

Location

Altana Pharma/Nycomed

Cologne, 51065, Germany

Location

Altana Pharma/Nycomed

Freising, 85356, Germany

Location

Altana Pharma/Nycomed

Germersheim, 76726, Germany

Location

Altana Pharma/Nycomed

Grünstadt, 67269, Germany

Location

Altana Pharma/Nycomed

Jülich, 52428, Germany

Location

Altana Pharma/Nycomed

Köthen, 6366, Germany

Location

Altana Pharma/Nycomed

Künzing, 94550, Germany

Location

Altana Pharma/Nycomed

Landsberg, 6188, Germany

Location

Altana Pharma/Nycomed

Langen, 63225, Germany

Location

Altana Pharma/Nycomed

Leipzig, 4105, Germany

Location

Altana Pharma/Nycomed

Ludwigshafen, 67067, Germany

Location

Altana Pharma/Nycomed

Lüneburg, 21335, Germany

Location

Altana Pharma/Nycomed

Mönchengladbach, 41239, Germany

Location

Altana Pharma/Nycomed

München, 80639, Germany

Location

Altana Pharma/Nycomed

Potsdam-Babelsberg, 14482, Germany

Location

Altana Pharma/Nycomed

Reinfeld, 23858, Germany

Location

Altana Pharma/Nycomed

Saarbrücken, 66111, Germany

Location

Altana Pharma/Nycomed

Budapest, 1125, Hungary

Location

Altana Pharma/Nycomed

Győr, 9024, Hungary

Location

Altana Pharma/Nycomed

Hatvan, 3000, Hungary

Location

Altana Pharma/Nycomed

Kaposvár, 7400, Hungary

Location

Altana Pharma/Nycomed

Kistarcsa, 2143, Hungary

Location

Altana Pharma/Nycomed

Miskolc, 3526, Hungary

Location

Altana Pharma/Nycomed

Szentes, 6600, Hungary

Location

Altana Pharma/Nycomed

Vác, 2601, Hungary

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gerald Holtmann, Prof.

  Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 13, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: April 1, 2007
• Last Updated: May 7, 2012

Record last verified: 2008-10

Locations

AU (4); HU (8); DE (23)