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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: |
NCT04032652 |
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Date of registration:
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04/12/2012 |
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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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Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
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Scientific title:
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Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT04032652 |
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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: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Contacts
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Name:
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Eli D Ehrenpreis, 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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NorthShore University HealthSystem |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Eligible subjects would be healthy males and females
- 18-45 years of age (inclusive)
- Within 20% of normal body weight at screening
- Who are able to give written informed consent.
Exclusion Criteria:
- History of any chronic illness
- Evidence of significant organic or psychiatric disease on a brief health questionnaire
- A history or presence of any condition causing malabsorption or an effect on
gastrointestinal motility
- A history of any gastrointestinal surgery
- A history of acute or chronic renal insufficiency
- Pre existing liver disease
- A history of severe allergic reaction to salicylates, aminosalicylates or any of the
ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they
are pregnant or lactating.
- Subjects will be required to refrain from any prescription or nonprescription drug or
herbal products except their birth control medications for gastrointestinal disorders
for 7 days prior to dosing and during the study, till its completion at the end of the
fifth visit.
Age minimum:
18 Years
Age maximum:
45 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: Rectal dialysis
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Procedure: Rectal dialysis
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Primary Outcome(s)
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Detection of 5-ASA
[Time Frame: 2 weeks after starting Asacol]
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Secondary Outcome(s)
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Change in Detected 5-ASA With Change in Ingested Asacol Dose
[Time Frame: 5 weeks after starting study]
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Secondary ID(s)
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EH 11-364
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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