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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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12 December 2020 |
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Main ID: |
NCT03408847 |
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Date of registration:
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24/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Monocultivar Coratina Extra Virgin Olive Oil in UC Patients
EVORCU |
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Scientific title:
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Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis |
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Date of first enrolment:
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November 20, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03408847 |
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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: Supportive Care. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Angelo Andriulli, MD |
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Address:
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Telephone:
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0039 0882 410263 |
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Email:
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a.andriulli@operapadrepio.it |
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Affiliation:
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Name:
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Fabrizio Bossa, MD |
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Address:
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Telephone:
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+39 0882416281 |
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Email:
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f.bossa@operapadrepio.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with active UC (diagnosed for at least 3 months) aged 18 to 70 years
- Patients with mild to moderate disease (calculated by Mayo score).
- Patients can provide their informed consent to participate in the study
Exclusion Criteria:
- Patients with Crohn's disease
- Patients with complicated disease, who are candidates for urgent surgery
- Patients with colostomy
- Patients with contraindications to steroid therapy (diabetes mellitus, severe
osteoporosis, vertebral fractures, previous intolerance to steroid therapy)
- Patients with unstable or inappropriately controlled cardiovascular, pulmonary,
hepatic, renal or hematologic diseases
- Patients who are not compliant
- Patients abusing alcohol or drugs
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis Chronic Mild
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Intervention(s)
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Combination Product: Beclomethasone dipropionate in addition to refined oil
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Combination Product: Beclomethasone dipropionate in addition to MC-EVOO
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Primary Outcome(s)
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Evaluation of the short-term clinical response
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Evaluation of adverse events
[Time Frame: 12 weeks]
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Evaluation of markers of inflammation
[Time Frame: 12 weeks]
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Evaluation of the clinical remission
[Time Frame: 12 weeks]
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Evaluation of the endoscopic remission
[Time Frame: 12 weeks]
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Secondary ID(s)
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EVO-RCU-2017
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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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