On Demand Treatment of Reflux Disease | NCT00184522

Studies
On Demand Treatment of Reflux Disease

NCT00184522

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 9, 2011Estimated

Enrollment

82Actual

Phase

Phase 4

Conditions

Gastroesophageal Reflux

Interventions

Aflurax
esomeprazole

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Nov 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2011

Last Update Posted Date

Aug 9, 2011Estimated

Name	Class
Ferrosan AS	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aflurax	Experimental	pectin-containing natural product	Drug: Aflurax
esomeprazole (Nexium)	Active Comparator	esomeprazole (Nexium)	Drug: esomeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aflurax	Drug		Aflurax	Pectin-containing nature product
esomeprazole

Measure	Description	Time Frame
Symptomatic relief

Measure	Description	Time Frame
Overall satisfaction

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per G Farup, PhD	Norwegian University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gjøvik Specialist Centre		Gjøvik		2800	Norway
Sykehuset Innlandet HF, Gjøvik

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19236727	Result	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.

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
C109521	idoflux
D064098	Esomeprazole

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds