Cromoglicate in Mastocytosis (NCT01701843) | Clinical Trial Compass
TerminatedPhase 2
Cromoglicate in Mastocytosis
Stopped: prematurely terminated because of low recruitment
Germany7 participantsStarted 2012-10
Plain-language summary
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent has been obtained
* Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
* Age between 18 and 70 years
* Either sex
* Any race or ethnicity
* Attending hospital outpatient clinic or the private practice of a dermatologist.
Exclusion Criteria:
* The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
* Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
* Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
* Evidence of severe renal dysfunction (creatinine \> 1,5 times upper reference value)
* Evidence of significant hepatic disease (liver enzymes \> 2 times upper reference value)
* Presence of active cancer which requires chemotherapy or radiation therapy
* 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 randomisation
* Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
* Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
* Confounding other dermatological diseases or conditions that can affect the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of mechanically induced changes of lesions