AllergyPhase 3NCT00293046
Assessment of Grazax® Treatment Compliance
A Phase 3 study testing ALK Grass tablet - use of compliance device in people with Allergy, run by ALK-Abelló A/S at 1 site in Austria.
Trial summary
This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- ALK Grass tablet - use of compliance device
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2006to Oct 2007
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grass pollen induced rhinoconjunctivitis
- Males and females, 18-65 years of age
- Positive skin prick test
Who cannot join
- Previous treatment with grass pollen allergen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).
- Conditions
- Allergy
- Being tested
- ALK Grass tablet - use of compliance device
- Keywords
- Allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK Grass tablet - use of compliance deviceBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of treatment compliance by recording of drug accountability
Secondary outcomes (1)
Recording of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kim Simonsen, MD, Study director, ALK-Abelló A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293046
- Sponsor's protocol ID
- GT-10
- Status last verified
- Sep 2008
- First submitted
- 16 Feb 2006
- Last updated
- 30 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00293046
- Acronym / sponsor ID
- GT-10
- Conditions
- Allergy
- Keywords
- Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Feb 2006 (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.
This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Grass pollen induced rhinoconjunctivitis
- Males and females, 18-65 years of age
- Positive skin prick test
Key exclusion criteria (1 listed)
- Previous treatment with grass pollen allergen
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 |
|---|---|---|
| ALK Grass tablet - use of compliance device | Biological | – |
Primary outcome
Assessment of treatment compliance by recording of drug accountability
1 secondary outcome
Recording of adverse events
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 30 Sep 2008.
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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.
Kim Simonsen, MD study director
ALK-Abelló A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALK Grass tablet - use of compliance device in people with Allergy, run by ALK-Abelló A/S at 1 site in Austria.
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 3 inclusion and 1 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 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Assessment of treatment compliance by recording of drug accountability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2008.