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| Name | Class |
|---|---|
| Trial Form Support S.L. | OTHER |
| Apices Soluciones S.L. | INDUSTRY |
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The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.
The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination.
The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus.
The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug.
The secondary objective is to evaluate the safety of CitraFleet.
In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrafleet | Experimental | The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h. |
|
| Klean Prep | Active Comparator | The day prior to the colonoscopy from 16:00h to 20:00h. |
|
| Citrafleet Exploratory | Experimental | The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium picosulphate, light magnesium oxide and anhydride citric acid. | Drug | 2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing. | 24 hours | |
| Percentage of subjects who find the agent easy to take or tolerable using a 5 point scale which assesses, the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug, recorded in the subject questionnaire | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse reactions. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A. Muñoz-Navas, M.D. | Clínica Universitaria de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Universitari Vall´d Hebron | Barcelona | Barcelona | 08035 | Spain | ||
| H. Clínic |
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|
| Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate. | Drug | 4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr). |
|
|
| Barcelona |
| Barcelona |
| 08036 |
| Spain |
| H. General Universitario Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| H. Universitario Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| H. General Universitario Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| H. Universitario Puerta de Hierro | Madrid | Madrid | 28222 | Spain |
| H. Infanta Elena | Valdemoro | Madrid | 28340 | Spain |
| H. Universitario Virgen de la Arrixaca | Murcia | Murcia | 30120 | Spain |
| H. Regional Universitario Carlos Haya | Málaga | Málaga | 29010 | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| H. Universitario Central de Asturias | Oviedo | Oviedo | 33006 | Spain |
| H. Virgen Macarena | Seville | Sevilla | 41009 | Spain |
| H. Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| H. Universitario La Fé | Valencia | Valencia | 46009 | Spain |
| H. Basurto | Bilbao | Vizcaya | 48013 | Spain |
| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
| D011092 | Polyethylene Glycols |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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