Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509275
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2007-07-30
Brief Title:
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis MTTP
Sponsor:
Stiefel a GSK Company
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase Ib Randomized Double Blind Placebo Controlled Study to Investigate the Pharmacokinetics Safety and Efficacy of 3 Different Doses of W0027 and Placebo Capsules in Subjects With Clinically and Mycologically Proven MTTP
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this phase Ib multi-centre randomized double-blind placebo-controlled parallel group study 120 subjects with moccasin type tinea pedis MTTP will be enrolled at approximately 11 centres in the USA Canada and Australia
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP Secondary objectives include assessment of the safety tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP Secondary objectives include assessment of the safety tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None