NCT00184522

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2002

Typical duration for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

August 9, 2011

Status Verified

September 1, 2005

Enrollment Period

2.3 years

First QC Date

September 15, 2005

Last Update Submit

August 8, 2011

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal RefluxEsomeprazoleDrug treatment

Outcome Measures

Primary Outcomes (1)

  • Symptomatic relief

Secondary Outcomes (1)

  • Overall satisfaction

Study Arms (2)

Aflurax

EXPERIMENTAL

pectin-containing natural product

Drug: Aflurax

esomeprazole (Nexium)

ACTIVE COMPARATOR

esomeprazole (Nexium)

Drug: esomeprazole

Interventions

AfluraxDRUG
Also known as: Pectin-containing nature product
Aflurax
esomeprazoleDRUG
Also known as: Nexium
esomeprazole (Nexium)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild and moderate reflux symptoms Age \> 17 years Informed consent -

You may not qualify if:

  • Other conditions that might explain the symptoms Abuse of drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Gjøvik Specialist Centre

Gjøvik, 2800, Norway

Location

Sykehuset Innlandet HF, Gjøvik

Gjøvik, 2819, Norway

Location

Sykehuset Innlandet HF, Hamar

Hamar, Norway

Location

Sykehuset Innlandet HF, Kongsvinger

Kongsvinger, Norway

Location

Sykehuset Innlandet HF, Lillehammer

Lillehammer, Norway

Location

Helse Nord-Møre og Romsdal

Molde, Norway

Location

Mosjøen sykehus

Mosjøen, Norway

Location

Helse Nord-Trøndelag

Namsos, Norway

Location

Sykehuset Innlandet HF, Tynset

Tynset, Norway

Location

Related Publications (1)

  • 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.

    PMID: 19236727RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

idofluxEsomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Per G Farup, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

August 1, 2002

Primary Completion

November 1, 2004

Study Completion

December 1, 2004

Last Updated

August 9, 2011

Record last verified: 2005-09

Locations

NO(9)