Cromoglicate in Mastocytosis

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Cromolyn Sodium

Criteria

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 symptoms of the target areas

• Known or suspected hypersensitivity to component(s) of investigational products.

• Current participation in any other interventional clinical trial.

• Subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation

• Previously randomised in this clinical trial

• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).

• Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.

• Females of child-bearing potential with positive pregnancy test at visit 1.

• Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)