Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02971007
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2016-11-10
Brief Title:
Safety and Efficacy of Oral Encochleated Amphotericin B CAMBMAT2203 in the Treatment of Vulvovaginal Candidiasis VVC
Sponsor:
Matinas BioPharma Nanotechnologies Inc
Organization:
Matinas BioPharma Nanotechnologies Inc
Study Overview
Official Title:
A Multi-Center Randomized Study to Evaluate the Safety Tolerability and Efficacy of Oral Encochleated Amphotericin B CAMBMAT2203 Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis VVC
Status:
COMPLETED
Status Verified Date:
2018-10
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:
This is a multi-center randomized study to evaluate the safety tolerability and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC
Detailed Description:
This is a multi-center randomized study to evaluate the safety tolerability and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups 200 mg CAMB 400 mg CAMB or fluconazole to achieve approximately 25 subjects in each group The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC The secondary efficacy objectives of this study included the clinical cure rate mycology eradication and responder outcome Tertiary objectives include pharmacokinetics
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups 200 mg CAMB 400 mg CAMB or fluconazole to achieve approximately 25 subjects in each group The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC The secondary efficacy objectives of this study included the clinical cure rate mycology eradication and responder outcome Tertiary objectives include pharmacokinetics
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