AllergyPhase 3NCT00421655
A Trial of Grazax in Subjects With Hayfever
A Phase 3 study testing Grazax in people with Allergy, run by ALK-Abelló A/S at 1 site in United States.
Trial summary
The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- Grazax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 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
- History of grass pollen allergy
- Positive skin prick test to grass
- Positive specific IgE to grass
Who cannot join
- FEV1 <70% of predicted value
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.
- Conditions
- Allergy
- Being tested
- Grazax
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazaxDrug
Tablets 75,000 SQT and matching placebo. One tablet daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Grazax |
| 2 | Placebo comparator | Not described Receives: Drug: Grazax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of allergy symptoms
Measured: Grass pollen season 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionOct 2007
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 329 participants (actual)
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
- NCT00421655
- Sponsor's protocol ID
- GT-14
- Status last verified
- Jun 2015
- First submitted
- 11 Jan 2007
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013 Jun 1;12:10. doi: 10.1186/1477-5751-12-10.
PubMed 23725348
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
- ClinicalTrials.gov ID
- NCT00421655
- Acronym / sponsor ID
- GT-14
- Conditions
- Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Jan 2007 (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 trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Grazax |
| 2 | Placebo comparator | Drug: Grazax |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of grass pollen allergy
- Positive skin prick test to grass
- Positive specific IgE to grass
Key exclusion criteria (1 listed)
- FEV1 <70% of predicted value
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 |
|---|---|---|
| GrazaxTablets 75,000 SQT and matching placebo. One tablet daily. | Drug | 1, 2 |
Primary outcome
Recording of allergy symptoms
Time frame: Grass pollen season 2007
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 24 Jun 2015.
- Derived from this study: PubMed 23725348Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013 Jun 1;12:10. doi: 10.1186/1477-5751-12-10.
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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 Grazax in people with Allergy, run by ALK-Abelló A/S at 1 site in United States.
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 24 Jun 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Recording of allergy symptoms (time frame: Grass pollen season 2007). 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 NCT00421655, 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 24 Jun 2015.