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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222131
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Indigestion Drug: Esomeprazole Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Inhibition of Gastric Acid Is the Key To Satisfactory Relief of Symptoms and Restoration of the Quality of Life in Patients With Epigastric Pain Related to Non-Ulcer Dyspepsia During Therapy With Esomeprazole
Study Start Date : October 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Placebo Comparator: 1
Placebo
Other: Placebo
Placebo

Active Comparator: 2
Esomeprazole
Drug: Esomeprazole
Esomeprazole 40 mg QD
Other Name: Nexium




Primary Outcome Measures :
  1. Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms [ Time Frame: 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 :
  1. Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours [ Time Frame: 8 Weeks ]
    Time (minutes) gastric pH remained >4.0 during 24-hours gastric pH monitoring.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise.

C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort.

D. Capable of and willing to give informed consent and comply with all study requirements.

Exclusion criteria:

A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.).

D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones).

J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day.

M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222131


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
AstraZeneca
Investigators
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Principal Investigator: Richard Mccallum, MD University of Kansas Medical Center
Principal Investigator: Jerzy Sarosiek, PhD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00222131    
Other Study ID Numbers: 8777
First Posted: September 22, 2005    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by University of Kansas Medical Center:
Epigastric Pain
Non-Ulcer Dyspepsia (NUD)
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action