AllergyPhase 4NCT00258141
Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects
A Phase 4 study testing Rupatadine in people with Allergy, run by J. Uriach and Company at 2 sites in Finland.
Trial summary
The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- Rupatadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesFinland
- Study dates
- Start not givento not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent history of suffering from mosquito-bite reactions.
- At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes
Who cannot join
- Pregnancy or lactating females
- Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study.
- Severe or moderate systemic illness
- Allergy to rupatadine or other antihistamines
- Anaphylaxis from mosquito bites
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Ulappatorin Lääkäriasema
Espoo
Leena Ackermann, MD
Koskiklinikka, Tampere Lääkärikeskus
Tampere, 33101
Ari Karppinen, MD
About this study
Official title: A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects
The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.
Read the detailed description
Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials.
Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.
- Conditions
- Allergy
- Being tested
- Rupatadine, Placebo
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bite lesion size (squared mm)
Secondary outcomes (1)
Pruritus on a Visual Analog Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timo Reunala, Prof., Principal investigator, Medical School, University of Tampere and Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258141
- Sponsor's protocol ID
- DM03RUP/IV/05
- Status last verified
- Nov 2005
- First submitted
- 23 Nov 2005
- Last updated
- 24 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects
- ClinicalTrials.gov ID
- NCT00258141
- Acronym / sponsor ID
- DM03RUP/IV/05
- Conditions
- Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- First posted
- 24 Nov 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 study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.
Detailed description
Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials.
Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent history of suffering from mosquito-bite reactions.
- At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes
Key exclusion criteria (5 listed)
- Pregnancy or lactating females
- Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study.
- Severe or moderate systemic illness
- Allergy to rupatadine or other antihistamines
- Anaphylaxis from mosquito bites
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 |
|---|---|---|
| Rupatadine | Drug | – |
| Placebo | Drug | – |
Primary outcome
Bite lesion size (squared mm)
1 secondary outcome
Pruritus on a Visual Analog Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2005.
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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.
Timo Reunala, Prof. principal investigator
Medical School, University of Tampere and Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rupatadine in people with Allergy, run by J. Uriach and Company at 2 sites in Finland.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo Reunala, Prof. ((+358) 331165167, timo.reunala@uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bite lesion size (squared mm). 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 24 Nov 2005.