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Trial record 16 of 26 for:    "Vulvovaginal Candidiasis" | "Hormone Antagonists"

Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

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ClinicalTrials.gov Identifier: NCT02971007
Recruitment Status : Completed
First Posted : November 22, 2016
Results First Posted : October 5, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Matinas BioPharma Nanotechnologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Vulvovaginitis Yeast Infection Yeast Infection Vaginal Candidiasis, Vulvovaginal Drug: Oral Encochleated Amphotericin B (CAMB) Drug: Fluconazole Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: CAMB 200 mg
200 mg CAMB (MAT2203) Oral Amphotericin B
Drug: Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
Other Name: MAT2203

Experimental: CAMB 400 mg
400 mg CAMB (MAT2203) Oral Amphotericin B
Drug: Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
Other Name: MAT2203

Active Comparator: Fluconazole 150 mg
Fluconazole Diflucan
Drug: Fluconazole



Primary Outcome Measures :
  1. Clinical Outcome Assessed at Test of Cure Visit [ Time Frame: 12 days ]
    Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)


Secondary Outcome Measures :
  1. Mycological Outcome Assessed at Test of Cure [ Time Frame: 12 days ]
    Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)

  2. Overall Response [ Time Frame: 12 Days ]
    Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).

  3. Change in Composite Clinical Cure Score [ Time Frame: Between randomization visit (Baseline) and Day 12 visit (Test of Cure) ]

    The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.

    The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Informed consent

Clinical diagnosis of moderate to severe VVC

Negative pregnancy test

Vaginal pH less than 4.5

Key Exclusion Criteria:

Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs

Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy

Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months

Has another cause of vulvovaginitis

Has other urogenital infection(s) that would potentially alter their response to disease

Has another vaginal or vulvar condition that would confound the interpretation of clinical response

Has significant laboratory abnormality at screening

Has any known azole-resistant Candida infection;

Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971007


  Show 23 Study Locations
Sponsors and Collaborators
Matinas BioPharma Nanotechnologies, Inc.
Investigators
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Study Director: Douglas Kling Matinas BioPharma Nanotechnologies, Inc.
  Study Documents (Full-Text)

Documents provided by Matinas BioPharma Nanotechnologies, Inc.:

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Responsible Party: Matinas BioPharma Nanotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT02971007     History of Changes
Other Study ID Numbers: MB-70005
First Posted: November 22, 2016    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Communicable Diseases
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents