Status:
COMPLETED
Study on Mastocytosis for Rupatadine Treatment
Lead Sponsor:
Marcus Maurer
Conditions:
Mastocytosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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-201...
Eligibility Criteria
Inclusion
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
- Age between 18 and 65 years.
- 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.
- Voluntarily signed written informed consent.
Exclusion
- The presence of permanent severe diseases, especially those affecting the immune system, except for mastocytosis
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper-/hypokalemia, bradycardia \< 50bpm, QTc interval \> 440ms
- Evidence of severe renal dysfunction (creatinine \> 1,5 x upper reference value)
- Evidence of significant hepatic disease (liver enzymes \> 2 x upper reference value)
- History of adverse reactions to RUP, or other ingredients of the IMP
- Presence of active cancer which requires chemotherapy or radiation therapy
- Aggressive systemic mastocytosis
- History or presence of alcohol abuse or drug addiction
- Participation in any clinical trial within 4 weeks prior to enrolment
- Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
- Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- Intake of oral corticosteroids within 14 days prior to the beginning of the study
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01481909
Start Date
September 1 2010
End Date
November 1 2011
Last Update
November 3 2016
Active Locations (1)
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1
University Charité
Berlin, Germany, Germany, 10117