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

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00829738
• Lead Sponsor: Nycomed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Results First Submitted: 2010-09-01
• Results First Submitted QC: 2010-09-01
• Results First Posted: 2010-09-24
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4188

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Pantoprazole	All patients enrolled

Primary Outcome Measures

Name	Time	Method
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn	14 days	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	14 days	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	14 days	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	14 days	Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Secondary Outcome Measures

Name	Time	Method
Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain	14 days	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	14 days	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea	14 days	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	14 days	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	14 days	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea	14 days	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Irritable Bowel Syndrome: Assessment of the Severity of Constipation	14 days	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	14 days	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	14 days	Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Überlingen, Germany