On Demand Treatment of Reflux Disease

This study has been completed.

First Received on September 15, 2005. Last Updated on August 8, 2011 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 natural product (Aflurax) with that esomeprazole (Nexium)

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Aflurax Drug: esomeprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall satisfaction [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	August 2002
Study Completion Date:	December 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aflurax pectin-containing natural product	Drug: Aflurax Other Name: Pectin-containing nature product
Active Comparator: esomeprazole (Nexium) esomeprazole (Nexium)	Drug: esomeprazole Other Name: Nexium

Detailed Description:

A randomized, controlled, open trial comparing the symptomatic effect of a pectin-containing product (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
Gjøvik Specialist Centre
Gjøvik, Norway, 2800
Sykehuset Innlandet HF, Hamar
Hamar, Norway
Sykehuset Innlandet HF, Kongsvinger
Kongsvinger, Norway
Sykehuset Innlandet HF, Lillehammer
Lillehammer, Norway
Helse Nord-Møre og Romsdal
Molde, Norway
Mosjøen sykehus
Mosjøen, Norway
Helse Nord-Trøndelag
Namsos, Norway
Sykehuset Innlandet HF, Tynset
Tynset, 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

Publications:

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.

Responsible Party:	Professor MD Per Farup, Norwegian University of science and technology
ClinicalTrials.gov Identifier:	NCT00184522 History of Changes
Other Study ID Numbers:	SLV 02-01973
Study First Received:	September 15, 2005
Last Updated:	August 8, 2011
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:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012