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

Completed

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

• Registration Number: NCT00561730
• Lead Sponsor: Nycomed

Brief Summary

The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Study Completion: 2008-12
• Results First Submitted: 2010-08-23
• Results First Submitted QC: 2010-08-23
• Results First Posted: 2010-09-16
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1995

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pantoprazole	Pantoprazole	All patients enrolled

Primary Outcome Measures

Name	Time	Method
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)	7 days	Assessment on a scale: Severity from 0=None to 10=Extremely strong

Secondary Outcome Measures

Name	Time	Method
Physician's Assessment of Heartburn	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Physician's Assessment of Acid Eructation	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Physician's Assessment of Painful Swallowing	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit	7 days	Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit	7 days	Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Zwickau, Germany