On Demand Treatment of Reflux Disease

August 8, 2011 updated by: Norwegian University of Science and Technology

Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflurax
pectin-containing natural product
Drug: Aflurax
Other Names:
  • Pectin-containing nature product
Active Comparator: esomeprazole (Nexium)
Drug: esomeprazole
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptomatic relief

Secondary Outcome Measures

Outcome Measure
Overall satisfaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Ferrosan AS

Investigators

  • Study Chair: Per G Farup, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLV 02-01973

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe