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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005115-13 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyethylene glycol | Active Comparator | 4 Liters of PEG administered split in 2 doses |
|
| oral sodium phosphate tablets | Experimental | oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral sodium phosphate tablets | Drug |
| ||
| polyethylene glycol |
| Measure | Description | Time Frame |
|---|---|---|
| overall quality of bowel cleansing | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Having a disease or condition as follows:
Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
Known allergy to any of the active ingredients or excipients of the study drugs.
History of phenylketonuria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | France | ||||
| Polyclinique Bordeaux Nord Aquitaine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27864718 | Derived | Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18. |
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| Drug |
|
| Bordeaux |
| France |
| Hopital Edouard Herriot | Lyon | France |
| Groupe Hospitalier Intercommunal Le Raincy-Montfermeil | Montfermeil | France |
| CHU Hotel Dieu | Nantes | France |
| Hopital l'Archet | Nice | France |
| CHU Cochin | Paris | France |
| Clinique Saint-Jean Languedoc | Toulouse | France |
| Sana Klinikum Lichtenberg | Berlin | Germany |
| Kreisklinik Biberach | Biberach | Germany |
| Klinikum Heidenheim | Heidenheim | Germany |
| Medizinische Klinik und Poliklinik II Munchen | München | Germany |
| Complejo Hospitalario de A Coruna | A Coruña | Spain |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital de Fuenlabrada | Fuenlabrada | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Universitarion Gregorio Maranon | Madrid | Spain |
| Clinica Universidad de Navarra | Pamplona | Spain |
| ID | Term |
|---|---|
| C018279 | sodium phosphate |
| D011092 | Polyethylene Glycols |
| 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 |
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