A Prospective, Randomized, Evaluator Blind, Active-Controlled, Parallel Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy

The objective is to demonstrate that investigational drug, Quiklean®, is not inferior to standard comparator, Klean-Prep with Dulcolax®, with respect to the overall quality of bowel preparation in subjects undergoing colonoscopy.

开始日期2019-06-10

申办/合作机构

Universal Integrated Corp. Consumer Products Pte Ltd.

100 项与 Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate 相关的临床结果

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100 项与 Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate 相关的转化医学

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项与 Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate 相关的文献（医药）

2011-09-01·Colorectal Disease3区 · 医学

Renal risks of sodium phosphate tablets for colonoscopy preparation: a review of adverse drug reactions reported to the US Food and Drug Administration

3区 · 医学

Article

作者: R. Semer ; E. D. Ehrenpreis ; D. Parakkal ; H. Du

AIMSodium-phosphate-containing colonoscopy preparations cause renal failure by the development of calcium phosphate nephropathy. Although Fleet's Phospho-Soda has been removed from the US market, sodium phosphate tablets sold as OsmoPrep and Visicol remain available. Our aim was to analyse renal risks of the sodium phosphate tablets.METHODWe conducted a retrospective study using the US Food and Drug Administration Adverse Event Reporting System, a voluntary reporting system available for public access. Renal adverse events were identified using search terms including renal impairment, increased blood urea nitrogen, increased creatinine, renal failure, acute renal failure, chronic renal failure, acute phosphate nephropathy, nephrocalcinosis, renal tubular necrosis, haemodialysis, nephropathy toxic, dialysis, peritoneal dialysis, renal injury, renal tubular disorder, decreased glomerular filtration rate and decreased creatinine clearance. Patient age, gender and body weight were compared with data for the general population in the National Health and Nutrition Examination Survey (NHANES).RESULTSIn total 2,097,223 files were extracted from the US Food and Drug Administration website for 2004-2008 and the first 9 months of 2009. Of these, 178 patients on tablet preparations (71% women) were identified, with increasing numbers of renal adverse drug reactions reported from tablet preparations each year. The mean weight for women with renal complications from tablet preparations was 68.57 ± 1.78 kg, significantly lower than the national average weight of 74 ± 0.5 kg for the same age group (P = 0.003) in NHANES.CONCLUSIONRenal adverse drug reactions from sodium phosphate tablets are more common in women with a mean body weight lower than the national average weight.

2007-04-01·Gastrointestinal Endoscopy1区 · 医学

Residue-free sodium phosphate tablets (OsmoPrep) versus Visicol for colon cleansing: a randomized, investigator-blinded trial

1区 · 医学

Article

作者: Demicco, Michael ; Safdi, Alan ; Dalke, Douglas ; Medoff, Jeffrey ; Zhang, Bing ; Wruble, Lawrence ; Karlstadt, Robyn G ; Bernstein, Jeffrey ; Rose, Martin ; Ettinger, Nancy

BACKGROUNDThe bowel purgative Visicol contains microcrystalline cellulose (MCC) residue, which may impair full visibility during a colonoscopy. An MCC residue-free sodium phosphate (RF-NaP; OsmoPrep) tablet was developed.OBJECTIVETo investigate appropriate RF-NaP dosing.DESIGNPhase 2, randomized, investigator-blinded study.SETTINGSix research centers in the United States.PATIENTS AND INTERVENTIONSPatients undergoing a colonoscopy received Visicol (n = 34) or 1 of 6 RF-NaP regimens administered as either split (S) dosing (the evening before and the day of colonoscopy) or evening-only (E) dosing. Dosing regimens for RF-NaP were 40 tablets S, 3 every 15 minutes (n = 33); 40 tablets S, 4 every 15 minutes (n = 34); 32 tablets E, 4 every 15 minutes (n = 34); 32 tablets S, 4 every 15 minutes (n = 36); 28 tablets E, 4 every 15 minutes (n = 34); 28 tablets S, 4 every 15 minutes (n = 34). Visicol was administered as 40 tablets S, 3 every 15 minutes.MAIN OUTCOME MEASUREOverall colon cleansing (OCC) was assessed by a physician questionnaire (4-point scale, based on colonic contents). An OCC rating of "excellent" or "good" was considered a response. Safety measures were also monitored.RESULTSSplit dosing with RF-NaP was associated with high OCC and achieved response rates of 90%, 97%, and 100% for 28, 32, and 40 tablets, respectively, compared with 86% for Visicol. In addition, RF-NaP evening-only regimen response rates were 90% (32 tablets) and 72% (28 tablets). Transient shifts in electrolyte levels were reduced, and GI adverse events were less common with lower RF-NaP dose regimens.CONCLUSIONSAdministration of RF-NaP retains the benefits of a tablet purgative but eliminates MCC issues. Split dosing and 32-tablet evening-only dosing of RF-NaP tablets were efficacious and well tolerated, and split dosing of RF-NaP tablets is recommended.

2005-11-01·Journal of the American Society of Nephrology1区 · 医学

An Underrecognized Cause of Chronic Renal Failure

1区 · 医学

Article

作者: Markowitz, Glen S. ; Radhakrishnan, Jai ; D'Agati, Vivette D. ; Stokes, M. Barry

The findings of diffuse tubular injury with abundant tubular calcium phosphate deposits on renal biopsy are referred to as nephrocalcinosis, a condition typically associated with hypercalcemia. During the period from 2000 to 2004, 31 cases of nephrocalcinosis were identified among the 7349 native renal biopsies processed at Columbia University. Among the 31 patients, 21 presented with acute renal failure (ARF), were normocalcemic, and had a history of recent colonoscopy preceded by bowel cleansing with oral sodium phosphate solution (OSPS) or Visicol. Because the precipitant was OSPS rather than hypercalcemia, these cases are best termed acute phosphate nephropathy. The cohort of 21 patients with APhN was predominantly female (81.0%) and white (81.0%), with a mean age of 64.0 yr. Sixteen of the 21 patients had a history of hypertension, 14 (87.5%) of whom were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. The mean baseline serum creatinine was 1.0 mg/dl, available within 4 mo of colonoscopy in 19 (90.5%) patients. Patients presented with ARF and a mean creatinine of 3.9 mg/dl at a median of 1 mo after colonoscopy. In a few patients, ARF was discovered within 3 d of colonoscopy, at which time hyperphosphatemia was documented. Patients had minimal proteinuria, normocalcemia, and bland urinary sediment. At follow-up (mean 16.7 mo), four patients had gone on to require permanent hemodialysis. The remaining 17 patients all have developed chronic renal insufficiency (mean serum creatinine, 2.4 mg/dl). Acute phosphate nephropathy is an underrecognized cause of acute and chronic renal failure. Potential etiologic factors include inadequate hydration (while receiving OSPS), increased patient age, a history of hypertension, and concurrent use of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.

项与 Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate 相关的新闻（医药）

2007-06-08

·BioSpace

Salix Pharmaceuticals, Ltd. Announces Imminent Launch of Visiclear(R) in Japan

RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that Zeria Pharmaceutical Co., Ltd. of Tokyo, Japan plans to launch Visiclear® Tablets for colon cleansing in Japan on June 15, 2007. Visiclear, or sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous, tablets are marketed in the United States under the trade name VISICOL®. In August 2001, InKine Pharmaceutical Company, Inc. (acquired by Salix in September 2005) licensed exclusive commercial rights in Japan to the product, the first approved and marketed tablet formulation colon cleansing agent, to Zeria.

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