MastocytosisPhase 2/3SMARTNCT01481909
Study on Mastocytosis for Rupatadine Treatment
A Phase 2/3 study testing Rupatadin in people with Mastocytosis, run by Marcus Maurer at 1 site in Germany.
Trial 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-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40 Abs. 4 AMG) Dr. med. F. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mastocytosis
- What is being tested?
- Rupatadin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Nov 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- 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,
- Additional assessment of symptoms,
- Assessment of life quality
Main criteria of evaluation:
Efficacy
- Conditions
- Mastocytosis
- Being tested
- Rupatadin
- Keywords
- Assessment of wheal and flare development, Assessment of life quality
- Medical subject headings
- Mastocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadinDrug
Also called Each tablet contains 10 mg RUP
20 mg, 28 days over 60 days
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | 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. Receives: Drug: Rupatadin |
| Rupafin | Active comparator | 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. Receives: Drug: Rupatadin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus
Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.
Measured: 10 weeks
Secondary outcomes (1)
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastocytosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Maurer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcus Maurer, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, MD, Principal investigator, University Berlin Charitè
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481909
- Sponsor's protocol ID
- SMART-2010-1
- Acronym
- SMART
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2011
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01481909
- Acronym / sponsor ID
- SMART / SMART-2010-1
- Conditions
- Mastocytosis
- Keywords
- Assessment of wheal and flare development, Assessment of life quality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marcus MaurerUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- Additional assessment of symptoms,
- Assessment of life quality
Main criteria of evaluation:
Efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: RupatadinAll 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. |
| Rupafin | Active comparator | Drug: RupatadinAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RupatadinAlso: Each tablet contains 10 mg RUP20 mg, 28 days over 60 days | Drug | Rupafin, Sugar Pill |
Primary outcome
Pruritus
Time frame: 10 weeks
Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.
1 secondary outcome
Questionaire
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Maurer, MD principal investigator
University Berlin Charitè
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rupatadin in people with Mastocytosis, run by Marcus Maurer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.