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

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ClinicalTrials.gov Identifier: NCT00222131
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 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
U.S. FDA Resources

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. Dyspeptic symptoms severity will be assessed with diary cards. Quality of life will be evaluated with a new disease-specific questionnaire. [ Time Frame: over 7 consecutive days of a 2 week run in & at the end of each tx period (4, 8, 12, 16 wks ]

Secondary Outcome Measures :
  1. 24 hour ph monitoring recording gastric ph during day and nighttime will be calculated. In addition, the percentage of time gastric ph remains >6.0,5,4,3,& >2.0 will be evaluated & correlated with degree of symptoms relief & QOL improvement. [ Time Frame: over 24 hours ]


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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 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
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
AstraZeneca
Investigators
Principal Investigator: Richard Mccallum, MD University of Kansas Medical Center
Principal Investigator: Jerzy Sarosiek, PhD University of Kansas Medical Center

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00222131     History of Changes
Other Study ID Numbers: 8777
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by University of Kansas Medical Center ( University of Kansas ):
Epigastric Pain
Non-Ulcer Dyspepsia (NUD)

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action