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PEG-Electrolyte Solution (FORTRANS®) With Mentholyptus Drops (Halls®) Versus Reduced Volume Ascorbic Acid Supplemented PEG-Electrolyte (MoviPrep®) in Colonoscopy Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01788709
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

Brief Summary:

The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing is of extreme importance to the endoscopist and the patient.

Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®) in bowel cleansing for colonoscopy.


Condition or disease Intervention/treatment Phase
Bowel Cleansing in Preparation for Colonoscopy Other: preparation cleaning solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: PEG-Electrolyte Solution (FORTRANS®) With Mentholyptus Drops (Halls®) Versus Reduced Volume Ascorbic Acid Supplemented PEG-Electrolyte (MoviPrep®) in Colonoscopy Preparation: A Randomised Controlled Study
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: MoviPrep

Arm Intervention/treatment
Active Comparator: A
Fortrans (split dose) + Mentholyptus drops
Other: preparation cleaning solution
Other Names:
  • Fortrans (split dose) + Mentholyptus drops
  • MoviPrep (split dose)

Active Comparator: B
MoviPrep (split dose)
Other: preparation cleaning solution
Other Names:
  • Fortrans (split dose) + Mentholyptus drops
  • MoviPrep (split dose)




Primary Outcome Measures :
  1. Bowel preparation quality [ Time Frame: 6 months ]
    Superiority of Fortrans + Halls to MoviPrep in cleansing the bowels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective colonoscopy
  • Consent to the study

Exclusion Criteria:

  • Pregnant or lactating women
  • Age less than 18 years
  • Significant gastroparesis
  • Gastric outlet obstruction
  • Ileus
  • Known or suspected bowel obstruction or perforation
  • Phenylketonuria
  • 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 (SBP ≥170 mm Hg, DBP ≥100 mm Hg)
  • Toxic colitis or megacolon
  • Patients with IBD
  • Status post partial colon resection
  • Severe constipation and laxative dependent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788709


Locations
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Lebanon
American University of Beirut Medical Center
Beirut, Lebanon, 00961
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Ala I Sharara, Prof American University of Beirut Medical Center
Study Director: Fayez S Sarkis, MD American University of Beirut Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01788709    
Other Study ID Numbers: IM.AS1.32
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: January 2013
Keywords provided by American University of Beirut Medical Center:
colonoscopy
preparation