On Demand Treatment of Reflux Disease

This study has been completed.
Sponsor:
Collaborator:
Ferrosan AS
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184522
First received: September 15, 2005
Last updated: August 8, 2011
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Aflurax
Drug: esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Symptomatic relief [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall satisfaction [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2002
Study Completion Date: December 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184522

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

Publications:
Responsible Party: Professor MD Per Farup, Norwegian University of science and technology
ClinicalTrials.gov Identifier: NCT00184522     History of Changes
Other Study ID Numbers: SLV 02-01973
Study First Received: September 15, 2005
Last Updated: August 8, 2011
Health Authority: Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on August 28, 2014