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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


Phase 2/Phase 3
18 Years
65 Years
Not Enrolling
Both
Mastocytosis

Thank you

Trial Information

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


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 § 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pruritus

Outcome Description:

Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.

Outcome Time Frame:

10 weeks

Safety Issue:

Yes

Principal Investigator

Marcus Maurer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Berlin Charitè

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

SMART-2010-1

NCT ID:

NCT01481909

Start Date:

September 2010

Completion Date:

November 2011

Related Keywords:

  • Mastocytosis
  • Assessment of wheal and flare development
  • Assessment of life quality
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma

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