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

Purpose

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

Condition	Intervention	Phase
Indigestion	Drug: Esomeprazole Other: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	October 2003
Estimated Study Completion Date:	January 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Other: Placebo Placebo Other Name: Placebo
Active Comparator: 2 Esomeprazole	Drug: Esomeprazole Esomeprazole 40 mg QD Other Name: Nexium

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222131

Sponsors and Collaborators

University of Kansas

AstraZeneca

Investigators

Principal Investigator:	Richard Mccallum, MD	University of Kansas
Principal Investigator:	Jerzy Sarosiek, PhD	University of Kansas

More Information

No publications provided

Responsible Party:	Jerzy Sarosiek, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00222131 History of Changes
Other Study ID Numbers:	8777
Study First Received:	September 13, 2005
Last Updated:	February 16, 2011
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of Kansas:

Epigastric Pain
Non-Ulcer Dyspepsia (NUD)

Additional relevant MeSH terms:

Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013