Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Phase 2

Completed

• Conditions: Indigestion
• Interventions: Other: Placebo; Drug: Esomeprazole

• Registration Number: NCT00222131
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Detailed Description

Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2017-04-07
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	Esomeprazole	Esomeprazole

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms	8 Weeks	Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.

Secondary Outcome Measures

Name	Time	Method
Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours	8 Weeks	Time (minutes) gastric pH remained \>4.0 during 24-hours gastric pH monitoring.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States