Gastroesophageal RefluxPhase 4NCT00184522
On Demand Treatment of Reflux Disease
A Phase 4 study testing Aflurax and esomeprazole in people with Gastroesophageal Reflux, run by Norwegian University of Science and Technology at 9 sites in Norway.
Trial summary
A comparison of the effect of on demand treatment with a pectin-containing natural product (Aflurax) with that esomeprazole (Nexium) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Aflurax and esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 9 sitesNorway
- Study dates
- Aug 2002to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild and moderate reflux symptoms Age > 17 years Informed consent -
Who cannot join
- Other conditions that might explain the symptoms Abuse of drugs or alcohol
- -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Gjøvik Specialist Centre
Gjøvik, 2800
Sykehuset Innlandet HF, Gjøvik
Gjøvik, 2819
Sykehuset Innlandet HF, Hamar
Hamar
Sykehuset Innlandet HF, Kongsvinger
Kongsvinger
Sykehuset Innlandet HF, Lillehammer
Lillehammer
Helse Nord-Møre og Romsdal
Molde
Mosjøen sykehus
Mosjøen
Helse Nord-Trøndelag
Namsos
Sykehuset Innlandet HF, Tynset
Tynset
About this study
Official title: Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.
A comparison of the effect of on demand treatment with a pectin-containing natural product (Aflurax) with that esomeprazole (Nexium)
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Aflurax, esomeprazole
- Keywords
- Gastroesophageal Reflux, Esomeprazole, Drug treatment
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfluraxDrug
Also called Pectin-containing nature product
esomeprazoleDrug
Also called Nexium
| Study group | Role | What they receive |
|---|---|---|
| Aflurax | Experimental | pectin-containing natural product Receives: Drug: Aflurax |
| esomeprazole (Nexium) | Active comparator | esomeprazole (Nexium) Receives: Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic relief
Secondary outcomes (1)
Overall satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionNov 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ferrosan AS
- Investigators
- Per G Farup, PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184522
- Sponsor's protocol ID
- SLV 02-01973
- Status last verified
- Sep 2005
- First submitted
- 15 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19236727
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT00184522
- Acronym / sponsor ID
- SLV 02-01973
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, Esomeprazole, Drug treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Ferrosan AS
- Study start
- Aug 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflurax | Experimental | Drug: Afluraxpectin-containing natural product |
| esomeprazole (Nexium) | Active comparator | Drug: esomeprazoleesomeprazole (Nexium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild and moderate reflux symptoms Age > 17 years Informed consent -
Key exclusion criteria (2 listed)
- Other conditions that might explain the symptoms Abuse of drugs or alcohol
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfluraxAlso: Pectin-containing nature product | Drug | Aflurax |
| esomeprazoleAlso: Nexium | Drug | esomeprazole (Nexium) |
Primary outcome
Symptomatic relief
1 secondary outcome
Overall satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- Results publication: PubMed 19236727Farup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per G Farup, PhD study chair
Norwegian University of Science and Technology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflurax and esomeprazole in people with Gastroesophageal Reflux, run by Norwegian University of Science and Technology at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic relief. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.