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On Demand Treatment of Reflux Disease

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Aflurax
esomeprazole
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Esomeprazole, Drug treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aflurax

esomeprazole (Nexium)

Arm Description

pectin-containing natural product

esomeprazole (Nexium)

Outcomes

Primary Outcome Measures

Symptomatic relief

Secondary Outcome Measures

Overall satisfaction

Full Information

First Posted
September 15, 2005
Last Updated
August 8, 2011
Sponsor
Norwegian University of Science and Technology
Collaborators
Ferrosan AS
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1. Study Identification

Unique Protocol Identification Number
NCT00184522
Brief Title
On Demand Treatment of Reflux Disease
Official Title
Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Ferrosan AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Gastroesophageal Reflux, Esomeprazole, Drug treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflurax
Arm Type
Experimental
Arm Description
pectin-containing natural product
Arm Title
esomeprazole (Nexium)
Arm Type
Active Comparator
Arm Description
esomeprazole (Nexium)
Intervention Type
Drug
Intervention Name(s)
Aflurax
Other Intervention Name(s)
Pectin-containing nature product
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
Nexium
Primary Outcome Measure Information:
Title
Symptomatic relief
Secondary Outcome Measure Information:
Title
Overall satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per G Farup, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Gjøvik Specialist Centre
City
Gjøvik
ZIP/Postal Code
2800
Country
Norway
Facility Name
Sykehuset Innlandet HF, Gjøvik
City
Gjøvik
ZIP/Postal Code
2819
Country
Norway
Facility Name
Sykehuset Innlandet HF, Hamar
City
Hamar
Country
Norway
Facility Name
Sykehuset Innlandet HF, Kongsvinger
City
Kongsvinger
Country
Norway
Facility Name
Sykehuset Innlandet HF, Lillehammer
City
Lillehammer
Country
Norway
Facility Name
Helse Nord-Møre og Romsdal
City
Molde
Country
Norway
Facility Name
Mosjøen sykehus
City
Mosjøen
Country
Norway
Facility Name
Helse Nord-Trøndelag
City
Namsos
Country
Norway
Facility Name
Sykehuset Innlandet HF, Tynset
City
Tynset
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19236727
Citation
Farup PG, Heibert M, Hoeg 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. doi: 10.1186/1472-6882-9-3.
Results Reference
result

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On Demand Treatment of Reflux Disease

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