Document Detail


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.
MedLine Citation:
PMID:  15709998     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
M Khashab; D K Rex
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  21     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2005 Feb 
Date Detail:
Created Date:  2005-02-15     Completed Date:  2005-05-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  465-8     Citation Subset:  IM    
Affiliation:
Indiana University Hospital, Indianapolis, IN 46202, USA. drex@iupui.edu
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MeSH Terms
Descriptor/Qualifier:
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:
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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