Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2010-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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verum, instruction, conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures.
dimetindene
receiving either dimetindene or a placebo (saline) via infusion
instruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
conditioning
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
verum, instruction, no conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
dimetindene
receiving either dimetindene or a placebo (saline) via infusion
instruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
placebo, instruction, conditioning
This group received a placebo (saline) as intravenously administered substance. But instructions about receiving dimetindene and its effectiveness were given. One classical conditioning process was applied during the skin prick test procedures.
instruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
conditioning
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
verum, no instruction, no conditioning
Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.
dimetindene
receiving either dimetindene or a placebo (saline) via infusion
Interventions
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dimetindene
receiving either dimetindene or a placebo (saline) via infusion
instruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
conditioning
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* basic experimental pruritus \>= 3 points on a numeric rating scale
* no acute eczema on their forearms
* no systemic treatments for skin diseases for at least four weeks
* no topical treatment on their arms for at least two weeks
Exclusion Criteria
* pregnancy and lactation
* serious dysfunctions of the liver, kidneys or thyroid
* prostatic hyperplasia
* patients with tumors, major cardiovascular diseases, immunosuppression
* glaucoma
18 Years
65 Years
ALL
No
Sponsors
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University of Hamburg-Eppendorf
OTHER
Margitta Worm
OTHER
Responsible Party
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Margitta Worm
Prof. Dr.
Principal Investigators
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Margitta Worm, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - University Medicine Berlin
Berlin, , Germany
University of Hamburg
Hamburg, , Germany
Countries
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Other Identifiers
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2008-008474-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PlacItch
Identifier Type: -
Identifier Source: org_study_id
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