Trials / Completed
CompletedNCT02971007
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 137 (actual)
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral Encochleated Amphotericin B (CAMB) | lipid-crystal nano-particle formulation amphotericin B |
| DRUG | Fluconazole |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-05-01
- Completion
- 2017-05-01
- First posted
- 2016-11-22
- Last updated
- 2018-11-02
- Results posted
- 2018-10-05
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02971007. Inclusion in this directory is not an endorsement.