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Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information on Various Types of Dysmotility
This study is currently recruiting participants.
Verified February 2012 by Helse Fonna

First Received on February 15, 2007.   Last Updated on February 9, 2012   History of Changes
Sponsor: Helse Fonna
Information provided by (Responsible Party): Valery Glazkov, Helse Fonna
ClinicalTrials.gov Identifier: NCT00437346
  Purpose

Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information.

Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. The most important relevant medical examination is gastroscopy, and if the findings are normal the condition is usually classified as functional dyspepsia.

Several disturbances of function are now known as potential causes of such symptoms, and the optimal choice of treatment may vary.

In the study the investigators plan to examine whether different types of functional disturbances respond differently to medical therapy. In particular, the investigators want to assess whether comprehensive and individualized information will influence the results of therapy. This has not been previously studied systematically.

The investigators also postulate that disturbances of function of the esophagus may cause complaints that should be classified as functional dyspepsia even if the symptoms are atypical. Few studies have been done to evaluate this hypothesis, and there may be potential consequences for choice of appropriate treatment.

In animal models and in humans is recently demonstrated that elevated gastric pH because of anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study and eventually development of food allergy will influence patient's condition in an observations period. That why we're observing IgE dynamics in our study.


Condition Intervention
Dyspepsia
Procedure: Individualized and comprehensive information
Drug: Lanzo Melt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility

Resource links provided by NLM:


Further study details as provided by Helse Fonna:

Primary Outcome Measures:
  • Improvement of symptom score [ Time Frame: november 2009-2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Patients is given thorough information based on the tests taken plus medical treatment.
Procedure: Individualized and comprehensive information
Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.
Drug: Lanzo Melt
30mg, od, 1/2 h before meal
Active Comparator: Group B
Patients receive simple written information based on the tests taken plus medical treatment.
Drug: Lanzo Melt
30mg, od, 1/2 h before meal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 - 60 years
  • Rome II criteria fulfilled
  • Helicobacter test negative (urease-test)
  • Informed consent

Exclusion Criteria:

  • Diabetes
  • Prior gastrointestinal surgery
  • Treatment with proton pump inhibitors / H2 blockers the last 30 days
  • Pregnancy / lactation
  • Current use of NSAIDs
  • Serious psychiatric illness
  • Serious egg allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437346

Contacts
Contact: Valerij Glazkov, MD +47-52732000 valery.glazkov@helse-fonna.no

Locations
Norway
Department of Medisin, Haugesund Hospital Recruiting
Haugesund, Norway, N-5504
Contact: Valerij Glazkov, MD         valery.glazkov@helse-fonna.no    
Surgical Department, Haugesund Hospital Recruiting
Haugesund, Norway, N-5504
Contact: Arne Christian Mohn, MD            
Department of Medicine, Haugesund Hospital Recruiting
Haugesund, Norway, N-5504
Contact: Ingrid Blomgren, MD            
Department of Radiology, Haugesund Hospital Recruiting
Haugesund, Norway, N-5504
Contact: Vivi Joraholmen, MD            
Gastro-group Recruiting
Haugesund, Norway, N-5527
Contact: Jens Ostborg, MD     +47-52866538     jostborg@broadpark.no    
Sponsors and Collaborators
Helse Fonna
Investigators
Principal Investigator: Valerij Glazkov, MD Department of Medicine, Haugesund Hospital, N-5504 Haugesund, Norway
Study Chair: Jan G. Hatlebakk, MD, PhD Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway
  More Information

Publications:
Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999 Sep;45 Suppl 2:II37-42. Review.
Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology. 2004 Oct;127(4):1239-55. Review. No abstract available.
Talley NJ, Verlinden M, Jones M. Can symptoms discriminate among those with delayed or normal gastric emptying in dysmotility-like dyspepsia? Am J Gastroenterol. 2001 May;96(5):1422-8.
Talley NJ, Locke GR, Lahr BD, Zinsmeister AR, Cohard-Radice M, D'Elia TV, Tack J, Earnest DL. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther. 2006 Apr 1;23(7):923-36.
Bolling-Sternevald E, Lauritsen K, Aalykke C, Havelund T, Knudsen T, Unge P, Ekstrom P, Jaup B, Norrby A, Stubberod A, Melen K, Carlsson R, Jerndal P, Junghard O, Glise H. Effect of profound acid suppression in functional dyspepsia: a double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol. 2002 Dec;37(12):1395-402.
Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005 Oct;100(10):2324-37.
Jones MP, Roth LM, Crowell MD. Symptom reporting by functional dyspeptics during the water load test. Am J Gastroenterol. 2005 Jun;100(6):1334-9.
Untersmayr E, Jensen-Jarolim E. The effect of gastric digestion on food allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):214-9. Review.

Responsible Party: Valery Glazkov, Dr., Helse Fonna
ClinicalTrials.gov Identifier: NCT00437346     History of Changes
Other Study ID Numbers: 15312
Study First Received: February 15, 2007
Last Updated: February 9, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Helse Fonna:
dyspepsia
functional dyspepsia
treatment
drug therapy
information

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on February 09, 2012