Last updated: 11/03/2018 16:49:39
Efficacy and safety study of 4 dose regimens of oral albaconazole in subjects with distal subungual onychomycosis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in subjects with distal subungual onychomycosis
Trial description: Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
The percentage of participants who achieve effective treatment at Week 52
Timeframe: Week 52
Secondary outcomes:
The percentage of participants who achieve clinical cure at Week 52
Timeframe: Week 52
The percentage of participants who achieve mycological cure at Week 52
Timeframe: Week 52
The percentage of participants who achieve complete cure at Week 52
Timeframe: Week 52
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
Timeframe: Baseline (Week 0/Day 1 or before) and up to Week 52
The percentage of participants with a global change score of cleared or much improved at Week 52
Timeframe: Week 52
Interventions:
Drug: Albaconazole 100mg
Drug: Albaconazole 200mg
Drug: Albaconazole 400mg
Drug: Placebo 400 mg
Enrollment:
582
Observational study model:
Not applicable
Primary completion date:
2010-19-02
Time perspective:
Not applicable
Clinical publications:
Bardur Sigurgeirsson, Koen van Rossem, Steven Malahias, & Kerry Raterink. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects with Distal Subungual Onychomycosis. J Am Acad Dermatol.
Medical condition
onychomycosis
Product
albaconazole
Collaborators
GSK
Study date(s)
July 2008 to February 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Subject aged 18 to 75 years.
- Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
- Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
- Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject aged 18 to 75 years.
- Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
- Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
- Subject is able to complete the study, comply with study instructions, and take study product orally.
- Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
- Women of childbearing potential must have a negative pregnancy test at enrollment.
- Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.
Exclusion criteria:
- Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
- Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
- Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
- Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
- Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.
- Subject has previously participated in a clinical study with albaconazole.
- Subject is not prepared to give up use of any nail cosmetic products for the duration of the study.
- Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
- Subject has any known liver disease or a history of liver toxicity with other drugs.
- Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
- Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail.
- Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
- Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
- Female subjects who are pregnant, trying to become pregnant, or lactating.
- Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
Trial location(s)
Location
North Bay Dermatology Centre Inc.
North Bay, Ontario, Canada, P1B 3Z7
Status
Study Complete
Location
UCSF Dermatology Research
San Francisco, CA, United States, 94115
Status
Study Complete
Location
Dermatology Centre, University of Iceland
Hudlaeknaslodin, Kopavogur, Iceland, 201
Status
Study Complete
Location
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
Status
Study Complete
Location
Northern California Research
Carmichael, CA, United States, 95608
Status
Study Complete
Location
Education and Research Foundation
Lynchburg, VA, United States, 24501
Status
Study Complete
Location
Therapeutics Clinical Research
San Diego, CA, United States, 92123
Status
Study Complete
Location
University of North Carolina at Chapel Hill
Chapel Hill, NC, United States, 27599
Status
Study Complete
Location
Tennessee Clinical Research
Nashville, TN, United States, 37215
Status
Study Complete
Location
Center for Dermatology Clinical Research
Fremont, CA, United States, 94538
Status
Study Complete
Location
Thomas J. Stephens & Associates, Inc. Colorado Research Center
Colorado Springs, CO, United States, 80915
Status
Study Complete
Location
Gwinnett Clinical Research Center, Inc.
Snellville, GA, United States, 30078
Status
Study Complete
Location
Oregon Dermatology & Research Centre
Portland, OR, United States, 97210
Status
Study Complete
Location
Miami Dermatology Research Institute LLC
North Miami Beach, FL, United States, 33169
Status
Study Complete
Location
Minnesota Clinical Study Center
Fridley, MN, United States, 55432
Status
Study Complete
Location
University of Alabama at Birmingham
Birmingham, AL, United States, 35233
Status
Study Complete
Location
DermatologyResearch Center
Salt Lake City, UT, United States, 84124
Status
Study Complete
Location
International Dermatology Research Inc
Miami, FL, United States, 33144
Status
Study Complete
Location
Greater Miami Skin & Laser Center
Miami Beach, FL, United States, 33140
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-19-02
Actual study completion date
2010-19-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114554 can be found on the GSK Clinical Study Register.
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