Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

Completed

• Conditions: Erosive Gastroesophageal Reflux Disease; Non-Erosive Reflux Disease
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00562094
• Lead Sponsor: Nycomed

Brief Summary

The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.

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
• Primary Completion: 2009-04
• Study Completion: 2009-04
• 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: 8616

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pantoprazole	Pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Assessment of the Severity of Sleep Disturbances	first and last visit (after a median of 18 days)	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole	last visit (after a median of 18 days)	Physician's assessment on a scale with; * considerably improved; * improved; * unchanged

Secondary Outcome Measures

Name	Time	Method
Assessment of the Severity of Heartburn	first and last visit (after a median of 18 days)	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Severity of Eructation/Acid Eructation	first and last visit (after a median of 18 days)	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Severity of Epigastric Complaints/Epigastric Pain	first and last visit (after a median of 18 days)	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Severity of Sensation of Fullness/Abdominal Distension	first and last visit (after a median of 18 days)	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Efficacy of Pantoprazole at Final Visit	last visit (after a median of 18 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	last visit (after a median of 18 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