Trial record 2 of 52 for:    Open Studies | "Dyspepsia"

Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information on Various Types of Dysmotility

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Helse Fonna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Valery Glazkov, Helse Fonna
ClinicalTrials.gov Identifier:
NCT00437346
First received: February 15, 2007
Last updated: February 9, 2012
Last verified: February 2012
  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
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, see Learn About Clinical Studies.

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:

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
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014