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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: |
NCT03581149 |
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Date of registration:
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27/03/2018 |
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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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Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients
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Scientific title:
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Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial |
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Date of first enrolment:
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March 26, 2018 |
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Target sample size:
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68 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03581149 |
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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: Diagnostic. Masking: Single (Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Louma Rustam, 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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Ala Sharara, M.D |
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Address:
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Telephone:
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00961893989 |
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Email:
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as08@aub.edu.lb |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with Ulcerative Colitis
- Patients undergoing elective outpatient colonoscopy
- Patients consenting to the study
Exclusion Criteria:
- Age less than 18 years
- Pregnant or lactating women
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
- Known or suspected bowel obstruction or perforation
- Phenylketonuria
- Toxic colitis or megacolon
- Having a stoma
- Compromised swallowing reflex or mental status
- Psychiatric disease or known or suspected poor compliance
- Severe chronic renal failure (creatinine clearance <30 mL/minute)
- Severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Dehydration
- Laxative use or dependency
- Chronic constipation (<3 spontaneous bm/week)
- Uncontrolled hypertension (systolic blood pressure =170 mm Hg, diastolic blood
pressure =100 mm Hg)
- Prior colon resection
- Age above 65 years
- Profusely bleeding patients with severe UC
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Sodium Picosulfate/Magnesium Citrate Laxative
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Drug: 2L polyethylene glycol/ascorbic acid
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Primary Outcome(s)
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Tolerability of the preparation as assessed by a Likert-type scale
[Time Frame: 1 year]
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Secondary Outcome(s)
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Assessment of adherence to protocol
[Time Frame: 1 year]
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Quality of the preparation as assessed by the Boston Bowel Preparation Scale.
[Time Frame: 1 year]
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Quality of the preparation as assessed by the Modified Aronchick scale.
[Time Frame: 1 year]
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Secondary ID(s)
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BIO-2017-0434
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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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