On Demand Treatment of Reflux Disease

Phase 4

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Aflurax; Drug: esomeprazole

• Registration Number: NCT00184522
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-11
• Study Completion: 2004-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflurax	Aflurax	pectin-containing natural product
esomeprazole (Nexium)	esomeprazole	esomeprazole (Nexium)

Primary Outcome Measures

Name	Time	Method
Symptomatic relief

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction

Trial Locations

Locations (9)

Gjøvik Specialist Centre; 🇳🇴 Gjøvik, Norway

Sykehuset Innlandet HF, Hamar; 🇳🇴 Hamar, Norway

Sykehuset Innlandet HF, Gjøvik; 🇳🇴 Gjøvik, Norway

Mosjøen sykehus; 🇳🇴 Mosjøen, Norway

Sykehuset Innlandet HF, Kongsvinger; 🇳🇴 Kongsvinger, Norway

Sykehuset Innlandet HF, Lillehammer; 🇳🇴 Lillehammer, Norway

Helse Nord-Møre og Romsdal; 🇳🇴 Molde, Norway

Helse Nord-Trøndelag; 🇳🇴 Namsos, Norway

Sykehuset Innlandet HF, Tynset; 🇳🇴 Tynset, Norway