Mastocytosis Clinical Trial
— SMARTOfficial title:
Study on Mastocytosis for Rupatadine Treatment An Exploratory Phase IV, Randomised, Double-blind, Placebo Controlled Crossover Study to Assess the Efficacy of 20 mg Rupatadine on the Treatment of
Study title:
An exploratory, randomised, double-blind, placebo controlled crossover study to assess the
efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.
Study code:
SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to §
40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,
Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,
D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical
Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin
Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin
Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II
Primary objective:
Reduction of wheal and flare type skin reaction after standardised provocation testing
assessed by volumetric and thermographic measurements.
Secondary objectives:
Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as
assessed by symptom score, DLQI, Itchy-QoL and VAS.
Study design:
An exploratory, randomised, double-blind, placebo controlled crossover study
Type and number of patients:
Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic
mastocytosis with skin involvement
Main criteria for inclusion:
Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid
or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode
of administration 20 mg Rupatadine or placebo before provocation testing, oral
administration (tablets)
Duration of treatment:
28 days (testing will be done at the day of last treatment)
Assessment of efficacy:
1. Assessment of wheal and flare development by planimetric analyses of digital
photographic, volumetric, and thermographic imaging (time lapse) before and after
treatment with study medication,
2. Additional assessment of symptoms,
3. Assessment of life quality
Main criteria of evaluation:
Efficacy
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign 2. Age between 18 and 65 years. 3. Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised. 4. Voluntarily signed written informed consent. Exclusion Criteria: 1. The presence of permanent severe diseases, especially those affecting the immune system, except for mastocytosis 2. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia 3. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper-/hypokalemia, bradycardia < 50bpm, QTc interval > 440ms 4. Evidence of severe renal dysfunction (creatinine > 1,5 x upper reference value) 5. Evidence of significant hepatic disease (liver enzymes > 2 x upper reference value) 6. History of adverse reactions to RUP, or other ingredients of the IMP 7. Presence of active cancer which requires chemotherapy or radiation therapy 8. Aggressive systemic mastocytosis 9. History or presence of alcohol abuse or drug addiction 10. Participation in any clinical trial within 4 weeks prior to enrolment 11. Commitment to an institution in terms of ยง 40 Abs. 1 S. 3 Nr. 4 AMG 12. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study 13. Intake of oral corticosteroids within 14 days prior to the beginning of the study 14. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study 15. Pregnancy or breast-feeding |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
Marcus Maurer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pruritus | Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements. | 10 weeks | Yes |
Secondary | Questionaire | Improvement of additional disease related symptoms and subjective affliction as measured by physician and patient global assessments, DLQI, Itchy-QoL and QoL(i)MaP*. *not validated questionnaire for mastocytosis symptoms |
10 weeks | Yes |
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