On Demand Treatment of Reflux Disease

This study has been completed.

First Received: September 15, 2005 Last Updated: April 18, 2006 History of Changes

Sponsor:	Norwegian University of Science and Technology
Collaborator:	Ferrosan AS
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184522

Purpose

A comparison of the effect of on demand treatment with a pectin-containing natur product (Aflurax) with that esomeprazole (Nexium)

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Esomeprazole Drug: Pectin-containing nature product	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Aflurax Versus Nexium Given on Demand to Patients With Gastro-Esophageal Reflux Disease.

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Symptomatic relief

Secondary Outcome Measures:

Overall satisfaction

Estimated Enrollment:	100
Study Start Date:	August 2002
Estimated Study Completion Date:	December 2004

Detailed Description:

A randomized, controlled, open trial comparing the symptomatic effect of a pectin-containing procuct (Aflurax) with that of esomeprazole (Nexium 20 mg) given on-demand for 6 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild and moderate reflux symptoms Age > 17 years Informed consent -

Exclusion Criteria:

Other conditions that might explain the symptoms Abuse of drugs or alcohol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184522

Locations

Norway
Sykehuset Innlandet HF, Gjøvik
Gjøvik, Norway, 2819
Helse Nord-Trøndelag
Namsos, Norway
Helse Nord-Møre og Romsdal
Molde, Norway
Sykehuset Innlandet HF, Tynset
Tynset, Norway
Mosjøen sykehus
Mosjøen, Norway
Gjøvik Specialist Centre
Gjøvik, Norway, 2800
Sykehuset Innlandet HF, Hamar
Hamar, Norway
Sykehuset Innlandet HF, Kongsvinger
Kongsvinger, Norway
Sykehuset Innlandet HF, Lillehammer
Lillehammer, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

Ferrosan AS

Investigators

Study Chair:

Per G Farup, PhD

Norwegian University of Science and Technology

More Information

No publications provided by Norwegian University of Science and Technology

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Farup PG, Heibert M, Høeg V. Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial. BMC Complement Altern Med. 2009 Feb 24;9:3.

Study ID Numbers:	SLV 02-01973
Study First Received:	September 15, 2005
Last Updated:	April 18, 2006
ClinicalTrials.gov Identifier:	NCT00184522 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Gastroesophageal Reflux
Esomeprazole
Drug treatment

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on February 09, 2010