Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information on Various Types of Dysmotility
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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 |
- 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 |
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| Contact: Valerij Glazkov, MD | +47-52732000 | valery.glazkov@helse-fonna.no |
| 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 | |
| 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 May 23, 2013