AllergyPhase 1NCT00330083
Safety of ALK Ragweed Tablet
A Phase 1 study testing ALK Ragweed Tablet in people with Allergy, run by ALK-Abelló A/S at 1 site in United States.
Trial summary
This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergy
- What is being tested?
- ALK Ragweed Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to not given
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ragweed pollen induced rhinoconjunctivitis
- Adults of either sex (18-50 years of age)
- Positive skin prick test to ragweed
Who cannot join
- Previous treatment with immunotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries Inc.
San Antonio, Texas, 78229
About this study
Official title: A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY
This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults
- Conditions
- Allergy
- Being tested
- ALK Ragweed 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 Ragweed 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 posted25 May 2006 (estimated)
- Study startMay 2006
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- George J. Atiee, MD, Principal investigator, Healthcare Discoveries Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330083
- Sponsor's protocol ID
- RT-01
- Status last verified
- Sep 2007
- First submitted
- 23 May 2006
- Last updated
- 21 Sep 2007
- Results posted
- No
Publications
Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.
PubMed 26507708
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY
- ClinicalTrials.gov ID
- NCT00330083
- Acronym / sponsor ID
- RT-01
- Conditions
- Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 25 May 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 ALK Ragweed Tablet is safe to use in adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ragweed pollen induced rhinoconjunctivitis
- Adults of either sex (18-50 years of age)
- Positive skin prick test to ragweed
Key exclusion criteria (1 listed)
- 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 Ragweed 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 21 Sep 2007.
- Derived from this study: PubMed 26507708Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.
Related trials for Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Not yet recruiting
Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy
Food Allergy in Children
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.
George J. Atiee, MD principal investigator
Healthcare Discoveries Inc.
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 Ragweed Tablet 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 21 Sep 2007. 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. 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?
On the ClinicalTrials.gov record for NCT00330083, 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 21 Sep 2007.