Type I AllergyPhase 4NCT00665483
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.
A Phase 4 study testing Skin Prick Test in people with Type I Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Multicenter Skin Prick Test Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type I Allergy
- What is being tested?
- Skin Prick Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Nov 2010
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- anamnesis referring to suspicion of an IgE-mediated allergy
- positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis
Who cannot join
- serious chronic diseases
- Other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen
Multicenter Skin Prick Test
- Conditions
- Type I Allergy
- Being tested
- Skin Prick Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prick TestOther
Skin Prick Test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Skin Prick Test Receives: Other: Skin Prick Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal trade-off between sensitivity and specificity
Measured: December 2007 - December 2008
Secondary outcomes (1)
Evaluation of the documentation of adverse events
Measured: January - December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I 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 4
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Wagner, MD, Principal investigator, Klinikum Darmstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665483
- Sponsor's protocol ID
- AL0205PR
- Other IDs
- 2006-005304-14
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2008
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen
- ClinicalTrials.gov ID
- NCT00665483
- Acronym / sponsor ID
- AL0205PR
- Conditions
- Type I Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Apr 2008 (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.
Multicenter Skin Prick Test
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Skin Prick TestSkin Prick Test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- anamnesis referring to suspicion of an IgE-mediated allergy
- positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis
Key exclusion criteria (2 listed)
- serious chronic diseases
- Other perennial allergies
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 |
|---|---|---|
| Skin Prick TestSkin Prick Test | Other | 1 |
Primary outcome
Optimal trade-off between sensitivity and specificity
Time frame: December 2007 - December 2008
1 secondary outcome
Evaluation of the documentation of adverse events
Time frame: January - December 2008
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 8 Nov 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
- Click here for information about this trial in the European Clinical Trials RegisterLink provided by the sponsor.
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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.
Nicola Wagner, MD principal investigator
Klinikum Darmstadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin Prick Test in people with Type I Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
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 2 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 8 Nov 2013. 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 Germany. 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?
Optimal trade-off between sensitivity and specificity (time frame: December 2007 - December 2008). 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 8 Nov 2013.