EUCTR2005-004611-30-NL
Active, not recruiting
Not Applicable
An open label phase IIa trial to assess efficacy and tolerability of a once a week oral dose of 200 mg R126638 in disto-lateral toenail onychomycosis. - R126638 in toenail onychomycosis
Barrier Therapeutics nv0 sites20 target enrollmentJuly 5, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Onychomycosis
- Sponsor
- Barrier Therapeutics nv
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female subjects 18 to 70 years old, inclusive.
- •2\.Clinical diagnosis of disto\-lateral onychomycosis of the toenails.
- •3\.Diagnosis confirmed by microscopic examination and culture.
- •4\.If the subject is of childbearing potential, she must have a negative urine pregnancy test at inclusion and agree to use effective forms of birth control (double barrier method) during the duration of the clinical trial or until the first menses after 60 days following the last dose of study medication, whichever is longer. She must be on a stable regimen, for at least one month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, IUD, condom and spermicidal agent or diaphragm and spermicidal agent.
- •5\.Availability of a signed informed consent prior to beginning protocol\-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this protocol.
- •6\.The subject is in good health and free of any disease or physical condition which, in the investigator’s opinion, might impair evaluation of onychomycosis of the toenail(s).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Distolateral\-toenail onychomycosis with involvement of the lanula.
- •2\.An involvement of the nail matrix.
- •3\.Longitudinal yellow streaks on the affected toenail
- •4\.Extensive hyperkeratosis (\>3mm nail thickness) on the most severely affected toenail.
- •5\.Toe nail onychomycosis limited to little toe nails only.
- •6\.Psoriasis or diabetes.
- •7\.History of significant sensitivity, or significant allergy to azoles or related drugs or any ingredient in the study medication.
- •8\.Severe coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive).
- •9\.History of heart\-failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders.
- •10\.Clinically significant abnormal ECG\-intervals or morphology of the ECG, QT or QTc\>450 ms.
Outcomes
Primary Outcomes
Not specified
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