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Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information.

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: NCT00437346
Recruitment Status : Terminated (The project leader left our hospital and the project were shut down.)
First Posted : February 21, 2007
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Helge Børresen, Helse Fonna

Brief Summary:

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 or disease Intervention/treatment Phase
Dyspepsia Procedure: Individualized and comprehensive information Drug: Lanzo Melt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility.
Actual Study Start Date : January 2007
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improvement of symptom score [ Time Frame: november 2009-2013 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00437346


Locations
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Norway
Department of Medicine, Haugesund Hospital
Haugesund, Norway, N-5504
Department of Medisin, Haugesund Hospital
Haugesund, Norway, N-5504
Department of Radiology, Haugesund Hospital
Haugesund, Norway, N-5504
Surgical Department, Haugesund Hospital
Haugesund, Norway, N-5504
Gastro-group
Haugesund, Norway, N-5527
Sponsors and Collaborators
Helse Fonna
Investigators
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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
Publications:

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Responsible Party: Helge Børresen, Dr., Helse Fonna
ClinicalTrials.gov Identifier: NCT00437346    
Other Study ID Numbers: 15312
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Keywords provided by Helge Børresen, Helse Fonna:
dyspepsia
functional dyspepsia
treatment
drug therapy
information
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive