NCT00437346

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

9.5 years

First QC Date

February 15, 2007

Last Update Submit

December 12, 2019

Conditions

Dyspepsia

Keywords

dyspepsiafunctional dyspepsiatreatmentdrug therapyinformation

Outcome Measures

Primary Outcomes (1)

  • Improvement of symptom score

    november 2009-2013

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients is given thorough information based on the tests taken plus medical treatment.

Procedure: Individualized and comprehensive informationDrug: Lanzo Melt

Group B

ACTIVE COMPARATOR

Patients receive simple written information based on the tests taken plus medical treatment.

Drug: Lanzo Melt

Interventions

Individualized and comprehensive informationPROCEDURE

Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.

Group A
Lanzo MeltDRUG

30mg, od, 1/2 h before meal

Group A

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Medicine, Haugesund Hospital

Haugesund, N-5504, Norway

Location

Department of Medisin, Haugesund Hospital

Haugesund, N-5504, Norway

Location

Department of Radiology, Haugesund Hospital

Haugesund, N-5504, Norway

Location

Surgical Department, Haugesund Hospital

Haugesund, N-5504, Norway

Location

Gastro-group

Haugesund, N-5527, Norway

Location

Related Publications (8)

  • Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II37-42. doi: 10.1136/gut.45.2008.ii37.

    PMID: 10457043BACKGROUND

  • Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology. 2004 Oct;127(4):1239-55. doi: 10.1053/j.gastro.2004.05.030. No abstract available.

    PMID: 15481001BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.2001.03683.x.

    PMID: 11374677BACKGROUND

  • 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. doi: 10.1111/j.1365-2036.2006.02845.x.

    PMID: 16573795BACKGROUND

  • 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. doi: 10.1080/003655202762671260.

    PMID: 12523588BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.2005.00225.x.

    PMID: 16181387BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.2005.40802.x.

    PMID: 15929766BACKGROUND

  • Untersmayr E, Jensen-Jarolim E. The effect of gastric digestion on food allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):214-9. doi: 10.1097/01.all.0000225163.06016.93.

    PMID: 16670517BACKGROUND

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valerij Glazkov, MD

    Department of Medicine, Haugesund Hospital, N-5504 Haugesund, Norway

    PRINCIPAL INVESTIGATOR

  • Jan G. Hatlebakk, MD, PhD

    Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 21, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 16, 2019

Record last verified: 2019-12

Locations

NO(5)