On Demand Treatment of Reflux Disease

NCT ID: NCT00184522

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aflurax

pectin-containing natural product

Group Type EXPERIMENTAL

Aflurax

Intervention Type DRUG

esomeprazole (Nexium)

esomeprazole (Nexium)

Group Type ACTIVE_COMPARATOR

esomeprazole

Intervention Type DRUG

Interventions

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Aflurax

Intervention Type DRUG

esomeprazole

Intervention Type DRUG

Other Intervention Names

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Pectin-containing nature product Nexium

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferrosan AS

INDUSTRY

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Norwegian University of science and technology

Principal Investigators

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Per G Farup, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

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Gjøvik Specialist Centre

Gjøvik, , Norway

Site Status

Sykehuset Innlandet HF, Gjøvik

Gjøvik, , Norway

Site Status

Sykehuset Innlandet HF, Hamar

Hamar, , Norway

Site Status

Sykehuset Innlandet HF, Kongsvinger

Kongsvinger, , Norway

Site Status

Sykehuset Innlandet HF, Lillehammer

Lillehammer, , Norway

Site Status

Helse Nord-Møre og Romsdal

Molde, , Norway

Site Status

Mosjøen sykehus

Mosjøen, , Norway

Site Status

Helse Nord-Trøndelag

Namsos, , Norway

Site Status

Sykehuset Innlandet HF, Tynset

Tynset, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 19236727 (View on PubMed)

Other Identifiers

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SLV 02-01973

Identifier Type: -

Identifier Source: org_study_id

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