Study on Mastocytosis for Rupatadine Treatment (SMART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01481909
First received: November 23, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Mastocytosis
Drug: Rupatadin
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Pruritus [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.


Secondary Outcome Measures:
  • Questionaire [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

    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



Enrollment: 30
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
All patients included in this study will be subjected at the screening visit to a standardized provocation of Darier's sign by a device for standardized provocation testing (Hartmann and Siebenhaar 2009). Patients that exhibit positive skin test reactions will be enrolled, provided that they meet all inclusion criteria and none of the exclusion criteria and that they give informed consent. Study patients will receive treatment for 28 days (minimal 25, maximal 30 days) before visit 1 and visit 2 including the same day before the provocation test (RUP 20mg/day or placebo according to randomization). All patients will receive antihistaminic rescue medication immediately after completing the testing when necessary.
Drug: Rupatadin
20 mg, 28 days over 60 days
Other Name: Each tablet contains 10 mg RUP
Active Comparator: Rupafin
All patients included in this study will be subjected at the screening visit to a standardized provocation of Darier's sign by a device for standardized provocation testing (Hartmann and Siebenhaar 2009). Patients that exhibit positive skin test reactions will be enrolled, provided that they meet all inclusion criteria and none of the exclusion criteria and that they give informed consent. Study patients will receive treatment for 28 days (minimal 25, maximal 30 days) before visit 1 and visit 2 including the same day before the provocation test (RUP 20mg/day or placebo according to randomization). All patients will receive antihistaminic rescue medication immediately after completing the testing when necessary.
Drug: Rupatadin
20 mg, 28 days over 60 days
Other Name: Each tablet contains 10 mg RUP

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481909

Locations
Germany
University Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Marcus Maurer
Investigators
Principal Investigator: Marcus Maurer, MD University Berlin Charitè
  More Information

No publications provided

Responsible Party: Marcus Maurer, Professor Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01481909     History of Changes
Other Study ID Numbers: SMART-2010-1
Study First Received: November 23, 2011
Last Updated: November 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Assessment of wheal and flare development
Assessment of life quality

Additional relevant MeSH terms:
Mastocytosis
Urticaria Pigmentosa
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Mastocytosis, Cutaneous
Pigmentation Disorders

ClinicalTrials.gov processed this record on August 28, 2014