On Demand Treatment of Reflux Disease

Gastroesophageal Reflux Clinical Trial

Official title:

Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184522
• Other study ID #: SLV 02-01973
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: August 8, 2011
• Start date: August 2002
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Aflurax

• esomeprazole

Locations

Country	Name	City	State
Norway	Gjøvik Specialist Centre	Gjøvik
Norway	Sykehuset Innlandet HF, Gjøvik	Gjøvik
Norway	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

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Ferrosan AS

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Farup PG, Heibert M, Høeg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic relief			No
Secondary	Overall satisfaction			No