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

This study is currently recruiting participants.
Verified November 2011 by Infante, Javier Molina, M.D.
Sponsor:
Information provided by (Responsible Party):
Infante, Javier Molina, M.D.
ClinicalTrials.gov Identifier:
NCT01481714
First received: November 25, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bowel Cleansing
Colonoscopy
 Drug: Sodium picosulphate, magnesium oxid and citric acid
Drug: Sodium picosulphate/magnesium oxide and citric acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase IV, Prospective, Randomized Study Comparing Preparation the Day Before and Split-dose Regimen With Sodium Picosulphate/Magnesium Citrate for Morning Colonoscopies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Infante, Javier Molina, M.D.:

Primary Outcome Measures:
  • Degree of bowel cleansing (Boston Scale 0-3) in each anatomical segment of the colon [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Rate of aspiration bronchopneumonia [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Adenoma detection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sodium Picosulphate preparation the day before

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
  • 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
Experimental: Split-dose sodium picosulphate preparation

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

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.

Detailed Description:

Justification of the study:

Several split-dose bowel cleansing regimens have raised over the last decade aiming to substitute standard preparation the day before. These split-dose regimens (based on sodium phosphate and polyethylene glycol solutions) have demonstrated better cleansing scores, so it is probably more important the time that preparation is given rather than the type of solution. However, the time to administer the second half of the solution in split-dose regimens for morning colonoscopies remains controversial. A major concern of split-dose regimens is the risk of aspiration pneumonia during sedation if liquids have been administered quite close to the procedure. As such, the second part of the preparation is usually given early in the morning (2-3 am) in order to have a safety-period of at least four hours prior to the colonoscopy. However, this is quite disturbing for patients and may hamper the adherence to further colonoscopies. Furthermore, On the other hand, no study addressing the role of split-dose Citrafleet has been published to date

Therefore it is necessary to make a controlled clinical trial to directly compare "the day before" and " split-dose" regimens with Citrafleet for morning colonoscopies. In order to maximize the efficacy of the split-dose regimens, the time period between fluids intake and the colonoscopy will be shortened up up to 2 hours for morning colonoscopies scheduled from 9 to 11 am and up to 3 hours for that scheduled after 11 am. The results of this study will conclude whether there is still room for improvement in bowel cleansing for morning colonoscopies, using more palatable low-volume solutions without interrupting sleep time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing routine elective colonoscopy

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481714

Contacts
Contact: Javier Molina-Infante, MD 0034627430248 xavi_molina@hotmail.com

Locations
Spain
Hospital San Pedro de Alcantara Recruiting
Caceres, Spain, 10003
Contact: Javier Molina-Infante, MD         xavi_molina@hotmail.com    
Principal Investigator: Javier Molina-Infante            
Sub-Investigator: Gema Vinagre-Rodriguez            
Sub-Investigator: Moises Hernandez-Alonso            
Sub-Investigator: Carmen Dueñas-Sadornil            
Sub-Investigator: Miguel Fernandez-Bermejo            
Sub-Investigator: Jose M Mateos-Rodriguez            
Sub-Investigator: Elisa Martin-Noguerol            
Sub-Investigator: Jesus M Gonzalez-Santiago            
Sub-Investigator: Carmen Martinez-Alcala            
Sponsors and Collaborators
Infante, Javier Molina, M.D.
Investigators
Principal Investigator: Javier Molina-Infante, MD Hospital San Pedro de Alcantara, Caceres, Spain
  More Information

Publications:

Responsible Party: Infante, Javier Molina, M.D.
ClinicalTrials.gov Identifier: NCT01481714     History of Changes
Other Study ID Numbers: CITRA-SPLIT
Study First Received: November 25, 2011
Last Updated: November 28, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Infante, Javier Molina, M.D.:
Sodium picosulphate
Split-dose
Bowel cleansing
colonoscopy
Degree of bowel cleansing during colonoscopy

Additional relevant MeSH terms:
Citric Acid
Magnesium Oxide
Picosulfate sodium
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Antacids
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013