Bee Venom AllergyPhase 3NCT00263952
Efficacy and Safety of a Purified Standardised Bee Venom Preparation
A Phase 3 study testing bee venom in people with Bee Venom Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bee Venom Allergy
- What is being tested?
- bee venom
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Apr 2010
- 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 bee venom allergy,
- Positive RAST for bee venom,
- Positive skin prick test for bee venom
Who cannot join
- Serious chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.
The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy
- Conditions
- Bee Venom Allergy
- Being tested
- bee venom
- Keywords
- Bee venom allergy, Specific immunotherapy
- Medical subject headings
- Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bee venomBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startMar 2003
- Primary completionJan 2005
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bee Venom 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annemie Narkus, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263952
- Sponsor's protocol ID
- Al0202ig
- Status last verified
- Mar 2013
- First submitted
- 9 Dec 2005
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.
- ClinicalTrials.gov ID
- NCT00263952
- Acronym / sponsor ID
- Al0202ig
- Conditions
- Bee Venom Allergy
- Keywords
- Bee venom allergy, Specific immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Dec 2005 (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 assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- History of bee venom allergy,
- Positive RAST for bee venom,
- Positive skin prick test for bee venom
Key exclusion criteria (1 listed)
- Serious chronic diseases
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 |
|---|---|---|
| bee venom | Biological | – |
Primary outcome
Not reported in the source record.
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 Mar 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
Related trials for Bee Venom Allergy
RecruitingObservational study
Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Bee Venom Allergy
Not yet recruiting
Virtual-reality Induced Immune Modulation in Allergic Patients
Hymenoptera Venom Allergy
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.
Annemie Narkus, M.D. principal investigator
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 bee venom in people with Bee Venom 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 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 4 Mar 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 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.
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 Mar 2013.