AllergyPhase 1NCT00310453
Tolerability of ALK Grass Tablet in Children
A Phase 1 study testing ALK Grass tablet in people with Allergy, run by ALK-Abelló A/S at 1 site in Spain.
Trial summary
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Allergy
- What is being tested?
- ALK Grass tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to May 2006
- Phase
- Phase 1
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Grass pollen induced rhinoconjunctivitis
- Boys and girls, 5-12 years of age
- Positive skin prick test to grass pollen
Who cannot join
- Severe asthma
- Previous treatment with immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years
- Conditions
- Allergy
- Being tested
- ALK Grass tablet
- 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 tabletBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by 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 posted4 Apr 2006 (estimated)
- Study startMar 2006
- Study completionMay 2006
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 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, Boege Alle 6-8, 2970 Hoersholm, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310453
- Sponsor's protocol ID
- GT-09
- Status last verified
- May 2006
- First submitted
- 2 Apr 2006
- Last updated
- 4 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
- ClinicalTrials.gov ID
- NCT00310453
- Acronym / sponsor ID
- GT-09
- Conditions
- Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- May 2006
- First posted
- 4 Apr 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.
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Grass pollen induced rhinoconjunctivitis
- Boys and girls, 5-12 years of age
- Positive skin prick test to grass pollen
Key exclusion criteria (2 listed)
- Severe asthma
- Previous treatment with immunotherapy
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 | Biological | – |
Primary outcome
Assessment of safety by 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 4 May 2006.
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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, Boege Alle 6-8, 2970 Hoersholm, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALK Grass tablet in people with Allergy, run by ALK-Abelló A/S at 1 site in Spain.
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 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 4 May 2006. 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 Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 safety by recording of adverse events. 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 4 May 2006.