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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Valery Glazkov, Helse Fonna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437346
First Posted: February 21, 2007
Last Update Posted: January 26, 2015
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.
Information provided by (Responsible Party):
Valery Glazkov, Helse Fonna
  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
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.

Resource links provided by NLM:


Further study details as provided by Valery Glazkov, Helse Fonna:

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

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
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
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:
Responsible Party: Valery Glazkov, Dr., Helse Fonna
ClinicalTrials.gov Identifier: NCT00437346     History of Changes
Other Study ID Numbers: 15312
First Submitted: February 15, 2007
First Posted: February 21, 2007
Last Update Posted: January 26, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms


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