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Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis

NCT02475447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2017-12-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Asimadoline

kappa-opioid receptor agonist

DRUG

Placebo

placebo-matched control

Sponsors & Collaborators

  • Tioga Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Dawn McGuire, MD FAAN · Tioga Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-06-30
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475447 on ClinicalTrials.gov