Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease - Full Text View

Sponsor:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00829738

Purpose

The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.

Condition	Intervention
Gastroesophageal Reflux Disease	Drug: Pantoprazole

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Pantoprazole 20/40 mg in Reflux-Associated Complaints With Focus on Gastrointestinal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: GERD Gas

Drug Information available for: Pantoprazole Pantoprazole sodium

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Secondary Outcome Measures:

Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Irritable Bowel Syndrome: Assessment of the Severity of Constipation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Enrollment:	4188
Study Start Date:	January 2009
Study Completion Date:	June 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 All patients enrolled	Drug: Pantoprazole This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Outpatients

Criteria

Main inclusion criteria:

Outpatients with gastroesophageal reflux disease (GERD)

Main exclusion criteria:

Criteria as defined in the Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829738

Show 717 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Thomas D. Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

No publications provided

Responsible Party:	Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00829738 History of Changes
Other Study ID Numbers:	P2-9999-011-DE
Study First Received:	January 13, 2009
Results First Received:	September 1, 2010
Last Updated:	May 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda Global Research & Development Center, Inc.:

PPI therapy
pantoprazole
GERD (Erosive Gastroesophageal Reflux Disease)

Additional relevant MeSH terms:

Gastroesophageal Reflux
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Digestive System Diseases
Signs and Symptoms

Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012