| Safety and colon-cleansing efficacy of a new residue-free formulation of sodium phosphate tablets. | |
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MedLine Citation:
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PMID: 17029618 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: A residue-free sodium phosphate tablet (RF-NaP) was formulated that lacks microcrystalline cellulose, which can appear as a whitish residue in the colon. A multicenter, randomized, investigator-blinded study was conducted to compare the colon-cleansing efficacy of 40 or 32 tablets of RF-NaP with the marketed 40-tablet NaP treatment regimen. METHODS: Eight hundred sixteen patients were randomized prior to colonoscopy to receive either 40 tablets (60 g) of NaP or RF-NaP or 32 tablets (48 g) of RF-NaP. Colon cleansing was assessed using a 4-point scale based on retained "colonic contents." The primary end point was overall colon-cleansing response rate to treatment (score of excellent/good) versus nonresponse (fair/inadequate). RESULTS: Seven hundred four patients were included in the efficacy analysis. The overall colon-cleansing response rates were comparable among treatment arms (94.5%, 97.0%, and 95.3% for NaP, RF-NaP 40, and RF-NaP 32 tablets, respectively). Ascending colon-cleansing response rates for RF-NaP 40 (95.7%) and 32 tablets (93.6%) were significantly better than for NaP tablets (88.5%, p < 0.03 for both). Patients treated with RF-NaP 32 tablets experienced less pronounced changes in electrolyte levels and fewer adverse events (138/239, 58%) compared with patients receiving NaP (161/238, 68%, p= 0.07) and RF-NaP 40 tablets (156/236, 66%, p= 0.03). The most common adverse events reported were abdominal distention, nausea, abdominal pain, and vomiting. CONCLUSIONS: Based on the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimen was superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing prior to colonoscopy. |
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Authors:
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Douglas K Rex; Howard Schwartz; Michael Goldstein; John Popp; Seymour Katz; Charles Barish; Robyn G Karlstadt; Martin Rose; Kelli Walker; Sandra Lottes; Nancy Ettinger; Bing Zhang |
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Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2006-10-04 |
Journal Detail:
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Title: The American journal of gastroenterology Volume: 101 ISSN: 0002-9270 ISO Abbreviation: Am. J. Gastroenterol. Publication Date: 2006 Nov |
Date Detail:
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Created Date: 2006-11-09 Completed Date: 2006-12-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0421030 Medline TA: Am J Gastroenterol Country: United States |
Other Details:
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Languages: eng Pagination: 2594-604 Citation Subset: IM |
Affiliation:
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Indiana University Medical Center, Indianapolis, Indiana 46202, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Cathartics / administration & dosage*, adverse effects Colonoscopy* Female Humans Male Middle Aged Patient Acceptance of Health Care Phosphates / administration & dosage*, adverse effects Tablets |
| Chemical | |
Reg. No./Substance:
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0/Cathartics; 0/Phosphates; 0/Tablets; 7632-05-5/sodium phosphate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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