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Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus associated with atopic dermatitis.
Asimadoline has been administered to over 1900 human subjects or patients in clinical trials and exhibits an acceptable safety profile. Due to its high selectivity for the kappa-opioid receptor, asimadoline does not produce mu-opioid like side-effects. Results from preclinical models indicate asimadoline significantly reduces the frequency of scratching induced by pruritic agents. This double-blind placebo-controlled clinical study is designed to evaluate the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus associated with atopic dermatitis.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Not yet recruiting
Published on BioPortfolio: 2015-06-19T04:23:23-0400
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Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological ...
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Chronic pruritus is defined by itching lasting 6 weeks or more and is known to be both a highly prevalent and burdensome symptom of many pruritogenic diseases. Its status as a symptom has many implica...
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Agents, usually topical, that relieve itching (pruritus).
Intense chronic itching in the anal area.
Intense itching of the external female genitals.
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Dermatitis means an inflammation of the skin. Contact dermatitis is a term used when this inflammation is caused by contact with something in the environment. The changes of dermatitis seen in the skin take the form of eczema; hence it may sometimes be r...