Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00730405
First received: August 4, 2008
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.


Condition Intervention Phase
Onychomycosis
Drug: Albaconazole 100mg
Drug: Albaconazole 200mg
Drug: Albaconazole 400mg
Drug: Placebo 400 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary endpoint is the proportion of subjects who achieve effective treatment at week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in unaffected nail from baseline to week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 584
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Albaconazole 100mg
Albaconazole for 36 weeks
Drug: Albaconazole 100mg
Albaconazole for 36 weeks
Active Comparator: Albaconazole 200mg
Albaconazole for 36 weeks
Drug: Albaconazole 200mg
Albaconazole for 36 weeks
Active Comparator: Albaconazole 400mg
Albaconazole for 36 weeks
Drug: Albaconazole 400mg
Albaconazole for 36 weeks
Active Comparator: Albaconazole 400mg 24 weeks, Placebo 12 weeks
Albaconazole for 24 weeks, Placebo for 12 weeks
Drug: Albaconazole 400mg
Albaconazole for 24 weeks, Placebo for 12 weeks
Drug: Placebo 400 mg
Placebo for 36 weeks
Placebo Comparator: Placebo 400 mg
Placebo for 36 weeks
Drug: Placebo 400 mg
Placebo for 36 weeks

Detailed Description:

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. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730405

  Show 33 Study Locations
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00730405     History of Changes
Other Study ID Numbers: 114554, W0027-10
Study First Received: August 4, 2008
Last Updated: August 9, 2012
Health Authority: Canada: Health Canada
Iceland: Icelandic Medicines Control Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Distal, Subungual onychomycosis
onychomycosis
nail fungus
Toenail fungus

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014