Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies

NCT01481714 | Unknown Phase 4 DMC

• 1 other identifier: CITRA-SPLIT
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy. Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is pointing out the need of switching from preparation the day before to regimens in which half or even more of the preparation is administered the same day of the procedure, which have extensively demonstrated to provide a significantly better cleansing, being well tolerated. Preparation can be fully administered the same day for afternoon procedures, whereas split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for early morning colonoscopies is still to be elucidated. The second part of the preparation for these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief that intake of fluids should be completely halted at least four hours prior to the colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed as two powder sachets. Mayor advantages in comparison with current alternatives are relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no data are available for split-dose sodium-picosulphate regarding colonoscopy in adults. The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate low-volume split-dose regimen, in which the second-half of the preparation and fluids intake are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning colonoscopies, comparing this split-dose regimen with standard cleansing the day before with sodium picosulphate/magnesium citrate.

Conditions

Bowel Cleansing; Colonoscopy

Keywords

Sodium picosulphate; Split-dose; Bowel cleansing; colonoscopy; Degree of bowel cleansing during colonoscopy

Outcome Measures

Primary Outcomes (1)

• Degree of bowel cleansing (Boston Scale 0-3) in each anatomical segment of the colon

  Boston Scale: 3: excellent; 2: good ; 1: fair; 0: poor. Anatomical segments of the colon: rectum, sigmoid colon, descending colon, transverse colon, ascending colon and cecum

  4 months

Secondary Outcomes (2)

• Rate of aspiration bronchopneumonia

  4 months

• Adenoma detection rate

  4 months

Study Arms (2)

Sodium Picosulphate preparation the day before

ACTIVE COMPARATOR

Preparation the day before of the procedure using sodium picosulphate: * A sachet mixed with 250 mL of water at 18:00 pm * A sachet mixed with 250 mL of water at 21:00 pm * A minimum of 4 litres of fluid were recommended throughout the preparation

Drug: Sodium picosulphate, magnesium oxid and citric acid

Split-dose sodium picosulphate preparation

EXPERIMENTAL

The day before the procedure: \- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids The day of the procedure: * A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am. * A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.

Drug: Sodium picosulphate/magnesium oxide and citric acid

Interventions

Sodium picosulphate, magnesium oxid and citric acid DRUG

* A sachet mixed with 250 mL of water at 18:00 pm * A sachet mixed with 250 mL of water at 21:00 pm * A minimum of 4 litres of fluid were recommended throughout the preparation

Sodium Picosulphate preparation the day before

Sodium picosulphate/magnesium oxide and citric acid DRUG

The day before the procedure: \- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids The day of the procedure: * A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am. * A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.

Split-dose sodium picosulphate preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing routine elective colonoscopy

You may not qualify if:

• pregnant or lactating women
• age less than 18 years
• significant gastroparesis or gastric outlet obstruction or ileus
• known or suspected bowel obstruction or perforation
• phenylketonuria or glucose-6-phosphate dehydrogenase deficiency
• severe chronic renal failure (creatinine clearance \< 30 mL/minute)
• severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
• dehydration
• severe acute inflammatory disease
• compromised swallowing reflex or mental status
• uncontrolled hypertension (systolic blood pressure \> 170 mm Hg ad/or diastolic blood pressure \> 100 mm Hg)
• toxic colitis
• megacolon

Sponsors & Collaborators

• Infante, Javier Molina, M.D.: lead

Study Sites (1)

Hospital San Pedro de Alcantara

Cáceres, Caceres, 10003, Spain

RECRUITING

Related Publications (14)

• Hoy SM, Scott LJ, Wagstaff AJ. Sodium picosulfate/magnesium citrate: a review of its use as a colorectal cleanser. Drugs. 2009;69(1):123-36. doi: 10.2165/00003495-200969010-00009.

  PMID: 19192941 BACKGROUND

• Love J, Bernard EJ, Cockeram A, Cohen L, Fishman M, Gray J, Morgan D. A multicentre, observational study of sodium picosulfate and magnesium citrate as a precolonoscopy bowel preparation. Can J Gastroenterol. 2009 Oct;23(10):706-10. doi: 10.1155/2009/385619.

  PMID: 19826647 BACKGROUND

• Turner D, Benchimol EI, Dunn H, Griffiths AM, Frost K, Scaini V, Avolio J, Ling SC. Pico-Salax versus polyethylene glycol for bowel cleanout before colonoscopy in children: a randomized controlled trial. Endoscopy. 2009 Dec;41(12):1038-45. doi: 10.1055/s-0029-1215333. Epub 2009 Dec 4.

  PMID: 19967619 BACKGROUND

• Hookey LC, Vanner SJ. Pico-salax plus two-day bisacodyl is superior to pico-salax alone or oral sodium phosphate for colon cleansing before colonoscopy. Am J Gastroenterol. 2009 Mar;104(3):703-9. doi: 10.1038/ajg.2008.167. Epub 2009 Feb 17.

  PMID: 19223885 BACKGROUND

• Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.

  PMID: 18179734 BACKGROUND

• Renaut AJ, Raniga S, Frizelle FA, Perry RE, Guilford L. A randomized controlled trial comparing the efficacy and acceptability of phospo-soda buffered saline (Fleet) with sodium picosulphate/magnesium citrate (Picoprep) in the preparation of patients for colonoscopy. Colorectal Dis. 2008 Jun;10(5):503-5. doi: 10.1111/j.1463-1318.2007.01383.x. Epub 2007 Sep 13.

  PMID: 17868404 BACKGROUND

• Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.

  PMID: 20485282 BACKGROUND

• Matro R, Shnitser A, Spodik M, Daskalakis C, Katz L, Murtha A, Kastenberg D. Efficacy of morning-only compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled single-blind study. Am J Gastroenterol. 2010 Sep;105(9):1954-61. doi: 10.1038/ajg.2010.160. Epub 2010 Apr 20.

  PMID: 20407434 BACKGROUND

• Seo EH, Kim TO, Kim TG, Joo HR, Park MJ, Park J, Park SH, Yang SY, Moon YS. Efficacy and tolerability of split-dose PEG compared with split-dose aqueous sodium phosphate for outpatient colonoscopy: a randomized, controlled trial. Dig Dis Sci. 2011 Oct;56(10):2963-71. doi: 10.1007/s10620-011-1772-1. Epub 2011 Jun 9.

  PMID: 21656179 BACKGROUND

• Kilgore TW, Abdinoor AA, Szary NM, Schowengerdt SW, Yust JB, Choudhary A, Matteson ML, Puli SR, Marshall JB, Bechtold ML. Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2011 Jun;73(6):1240-5. doi: 10.1016/j.gie.2011.02.007.

  PMID: 21628016 BACKGROUND

• Huffman M, Unger RZ, Thatikonda C, Amstutz S, Rex DK. Split-dose bowel preparation for colonoscopy and residual gastric fluid volume: an observational study. Gastrointest Endosc. 2010 Sep;72(3):516-22. doi: 10.1016/j.gie.2010.03.1125. Epub 2010 Jun 19.

  PMID: 20646700 BACKGROUND

• Di Palma JA, Rodriguez R, McGowan J, Cleveland Mv. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009 Sep;104(9):2275-84. doi: 10.1038/ajg.2009.389. Epub 2009 Jul 7.

  PMID: 19584830 BACKGROUND

• Gupta T, Mandot A, Desai D, Abraham P, Joshi A, Shah S. Comparison of two schedules (previous evening versus same morning) of bowel preparation for colonoscopy. Endoscopy. 2007 Aug;39(8):706-9. doi: 10.1055/s-2007-966375.

  PMID: 17661245 BACKGROUND

• Longcroft-Wheaton G, Bhandari P. Same-day bowel cleansing regimen is superior to a split-dose regimen over 2 days for afternoon colonoscopy: results from a large prospective series. J Clin Gastroenterol. 2012 Jan;46(1):57-61. doi: 10.1097/MCG.0b013e318233a986.

  PMID: 22064553 BACKGROUND

MeSH Terms

Interventions

picosulfate sodium; Citric Acid; Magnesium Oxide

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Javier Molina-Infante, MD

  Hospital San Pedro de Alcantara, Caceres, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Molina-Infante, MD

CONTACT

0034627430248; xavi_molina@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

ES (1)