| Efficacy and tolerability of a new formulation of sodium phosphate tablets (INKP-101), and a reduced sodium phosphate dose, in colon cleansing: a single-center open-label pilot trial. | |
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MedLine Citation:
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PMID: 15709998 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The tablet form of sodium phosphate for bowel preparation for colonoscopy contains microcrystalline cellulose. This inactive ingredient produces a residue that obscures mucosal visualization and is time-consuming to remove during colonoscopy. AIM: To perform an open-label study of efficacy and tolerability of a modified formulation with microcrystalline cellulose reduced by 50% (code named INKP-101) and a lower total dose of sodium phosphate. METHODS: Patients scheduled for colonoscopy self-administered 28 INKP-101 tablets (42 g sodium phosphate). Colon cleansing efficacy was evaluated using a standard 4-point scoring system and the amount of microcrystalline cellulose present and time spent removing it using an 8-point scale. RESULTS: A total of 31 patients were screened and enrolled. Thirty patients had a colonoscopy and were evaluated for colon cleansing efficacy. Overall colon cleansing was rated as excellent and good in 90% and 10% of patients respectively. About 77% of patients had microcrystalline cellulose scores of 2 or 3 (corresponding to <1 or 1-2 min spent removing microcrystalline cellulose, respectively). The drug was well-tolerated and adverse events were generally benign. CONCLUSION: A new formulation of sodium phosphate with reduced microcrystalline cellulose and a lower total dose of sodium phosphate was effective for colonoscopy and well-tolerated. |
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Authors:
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M Khashab; D K Rex |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Alimentary pharmacology & therapeutics Volume: 21 ISSN: 0269-2813 ISO Abbreviation: Aliment. Pharmacol. Ther. Publication Date: 2005 Feb |
Date Detail:
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Created Date: 2005-02-15 Completed Date: 2005-05-24 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8707234 Medline TA: Aliment Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 465-8 Citation Subset: IM |
Affiliation:
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Indiana University Hospital, Indianapolis, IN 46202, USA. drex@iupui.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Cathartics / administration & dosage*, adverse effects, chemistry Cellulose / chemistry Chemistry, Pharmaceutical Colonoscopy Crystallization Female Humans Male Middle Aged Phosphates / administration & dosage*, adverse effects, chemistry Pilot Projects Self Administration Tablets |
| Chemical | |
Reg. No./Substance:
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0/Cathartics; 0/Phosphates; 0/Tablets; 7632-05-5/sodium phosphate; 9004-34-6/Cellulose |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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