Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis
NCT ID: NCT02475447
Last Updated: 2017-12-13
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
PHASE2
249 participants
INTERVENTIONAL
2015-07-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo-matched tablets twice daily for 4 weeks.
Placebo
placebo-matched control
Asimadoline
Asimadoline tablets twice daily (5 mg total daily dose) for 8 weeks.
Asimadoline
kappa-opioid receptor agonist
Interventions
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Asimadoline
kappa-opioid receptor agonist
Placebo
placebo-matched control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female subject aged 18 years or older (no upper age limit)
3. Established clinical diagnosis of atopic dermatitis for at least 6 months
4. Itching Visual Analog Scale (VAS) average worst itching score of at least 40 mm on a 100 mm scale
5. Female subject of childbearing potential and male subject of procreative capacity agree to use an effective method of contraception for the duration of the study
Exclusion Criteria
2. Received phototherapy (ultraviolet B, psoralen plus ultraviolet A) within the previous 4 weeks
3. Received treatment with any of the following within the previous 2 weeks:
\- Topical or oral immunosuppressants or calcineurin inhibitors, sedating anti-histamines or anti-histamines taken for pruritus treatment, prescription topical corticosteroid creams or ointments, any other oral or topical steroids, aprepitant, naltrexone, pregabalin, gabapentin, or tricyclic antidepressants, or any other medications that, in the investigator's judgement, could affect the subject's pruritus or atopic dermatitis, and that are not specified below
OR taking any of the following and has not been on stable use for at least the previous 4 weeks:
\- Non-prescription topical hydrocortisone creams or ointments, lotions, moisturizers, emollients, bath oil treatments, non-sedating oral anti-histamines being taken for allergy treatment, selective serotonin reuptake inhibitor (SSRI) antidepressants.
4. Currently participating in other investigational clinical studies or having received investigational drugs in a clinical research study within the previous 3 months. Subjects currently enrolled in an observational study are eligible for participation in this study, however subjects must not enroll in a new observational study during the course of their participation in this study
5. Pruritus due to conditions other than atopic dermatitis (e.g., hepatitis, biliary cirrhosis, scabies) or due to medications known to cause pruritus
6. Acute illnesses, uncontrolled or unmanaged diabetes or thyroid disease, decompensated heart failure, cirrhosis or liver failure, chronic kidney disease, or uncontrolled psychiatric disease
7. Evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected) within the previous 5 years
8. History of HIV infection
9. History of alcohol or drug abuse within the past 3 years
10. Diseases or conditions that could, in the opinion of the investigator, interfere with the assessment of safety and efficacy of the study drug and compliance of the subject with study visits/procedures (e.g. exacerbation of multiple sclerosis or other comorbid conditions)
11. Use of any product that acts as an inhibitor of P-glycoprotein (P-gp) or as a P-gp substrate (with the exception of topical ketoconazole product for skin or scalp) within the previous 4 weeks
12. Known allergy to asimadoline or its drug components.
18 Years
ALL
No
Sponsors
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Tioga Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Dawn McGuire, MD FAAN
Role: STUDY_DIRECTOR
Tioga Pharmaceuticals, Inc.
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Axis Clinical Research
Los Angeles, California, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, United States
Forefront Dermatology
Carmel, Indiana, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
The Dermatology Group
Verona, New Jersey, United States
Corning Center for Clinical Research
Corning, New York, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, United States
Temple Itch Center
Philadelphia, Pennsylvania, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Medical Research South
Charleston, South Carolina, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
Dermatology Treatment and Research Center, PA
Dallas, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Countries
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Other Identifiers
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ASMP2006
Identifier Type: -
Identifier Source: org_study_id