Evaluación de la eficacia clinica, seguridad y actividad farmacologica de UR-1505 en voluntarios con alergia a niquel: estudio aleatorizado, doble ciego, cruzado y con control activo
- Conditions
- Volunteers with nickel allergy
- Registration Number
- EUCTR2005-005677-30-ES
- Lead Sponsor
- J. Uriach y Compañia, S. A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Volunteers with nickel allergy (4patch test)
Age 18--55 years old
Both sexes
No relevant medical history
No relevant physical examination
Informed consent signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Drug, xantines or alcohol abuse
Drug intake in the previous 48 hours
Investigational drug intake in the 3 previous months
Breast feeding or pregnanacy womwn
Some relevant disease
Not anticonceptival measures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of UR-1505 in the treatment of nickel allergy;Secondary Objective: To evaluate the safety of the treatments;Primary end point(s): Evaluate the allergic reaction by the physician global scale on day 4
- Secondary Outcome Measures
Name Time Method