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

NCT00730405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2018-03-12

Study results available
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Summary

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

Conditions

  • Onychomycosis

Interventions

DRUG

Albaconazole 100mg

Albaconazole for 36 weeks

DRUG

Albaconazole 200mg

Albaconazole for 36 weeks

DRUG

Albaconazole 400mg

Albaconazole for 36 weeks

DRUG

Albaconazole 400mg

Albaconazole for 24 weeks, Placebo for 12 weeks

DRUG

Placebo 400 mg

Placebo for 36 weeks

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-16
Primary Completion
2010-02-19
Completion
2010-02-19

Countries

  • United States
  • Canada
  • Iceland

Study Locations

More Related Trials

Entities

Companies

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 NCT00730405 on ClinicalTrials.gov