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This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picoprep | Experimental | sodium picosulfate, magnesium oxide and citric acid |
|
| Mannitol and Bisacodyl | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium picosulfate, magnesium oxide and citric acid (Picoprep®) | Drug |
| ||
| mannitol |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects classified as success (Aronchick scale) | Defined as excellent or good according to the Aronchick scale | At visit 2 (day 1 of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects classified as success (Ottawa scale) | Defined as excellent, good or fair according to the Ottawa scale | At visit 2 (day 1 of colonoscopy) |
| Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country) | São Paulo | Brazil |
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| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
| D008277 | Magnesium Oxide |
| D019343 | Citric Acid |
| D008353 | Mannitol |
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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| Drug |
|
| Bisacodyl | Drug |
|
As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire |
| At visit 2 (day 1 of colonoscopy) |
| Subject satisfaction (Likert scale) | As assessed by a subject survey using a 3 point Likert scale | At visit 2 (day 1 of colonoscopy) |
| D002951 |
| Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |