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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
NCT02543827 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the Efficacy and Safety of MV140
MV140 |
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Scientific title:
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Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02543827 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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United Kingdom
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Contacts
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Name:
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Alfonso Sánchez, PhD; MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Fernanda Lorenzo, PhD; MD-prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Manuel José Vicente, PhD; MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Isidoro Martín, PhD; MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stephen Foley, FRCS (Urol) |
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women who gave their informed consent.
- Age between 18 and 75 years.
- Must be able to meet the dosage regimen.
- Subjects who had had at least 5 episodes of cystitis in the last 12 months.
- Subjects who had not responded to hygienic-sanitary measures and / or suppressive
treatment and / or postcoital prophylaxis.
- Subjects who were free of urinary tract infections at the time of inclusion in the
study.
Exclusion Criteria:
- Had not given their informed consent.
- Age was not within the established age range.
- Could not offer cooperation and/or had severe psychiatric disorders.
- Presented a pathologic post-micturition residue.
- Presented moderate to severe incontinence.
- Presented genital tumours.
- Presented Urinary tract tumours.
- Presented lithiasis.
- Presented alterations in the immune system.
- Presented complicated UTIs.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infection Bacterial
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Intervention(s)
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Biological: MV140
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Biological: Placebo
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Primary Outcome(s)
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Decrease in the number of RUTI exacerbations.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Health resource consumption
[Time Frame: 1 year]
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Severity of RUTI exacerbations
[Time Frame: 1 year]
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Changes from baseline in RUTI Assessment Test
[Time Frame: 1 year]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: 1 year]
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Medication consumption
[Time Frame: 1 year]
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Number of visits to the emergency service
[Time Frame: 1 year]
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First RUTI exacerbation
[Time Frame: 1 year]
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Number of hospitalizations due to RUTI exacerbations
[Time Frame: 1 year]
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Percentage of difference in immunological parameters from baseline to end of the trial
[Time Frame: 1 year]
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Secondary ID(s)
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MV140-SLG-003
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2013-001838-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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