On Demand Treatment of Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184522
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 9, 2011
Ferrosan AS
Information provided by:
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Aflurax Drug: esomeprazole Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.
Study Start Date : August 2002
Primary Completion Date : November 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Symptomatic relief

Secondary Outcome Measures :
  1. Overall satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184522

Gjøvik Specialist Centre
Gjøvik, Norway, 2800
Sykehuset Innlandet HF, Gjøvik
Gjøvik, Norway, 2819
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
Study Chair: Per G Farup, PhD Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Professor MD Per Farup, Norwegian University of science and technology Identifier: NCT00184522     History of Changes
Other Study ID Numbers: SLV 02-01973
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: September 2005

Keywords provided by Norwegian University of Science and Technology:
Gastroesophageal Reflux
Drug treatment

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action