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The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution

This study is currently recruiting participants.
Verified January 2013 by American University of Beirut Medical Center
Sponsor:
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01541683
First received: February 21, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.


Condition Intervention
Colon Cancer
 Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
Other: PEG solution (Fortrans®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy
U.S. FDA Resources

Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • measurement of Palatability of the PEG-electrolyte solution [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: No ]
    patients will be asked to assess the palatability of the colon preparation solution (Fortrans®) by giving it a score on a scale from 1 to 5 with 1 being disgusting and 5 being tasty after drinking the whole solution and immediately prior to the colonoscopy


Secondary Outcome Measures:
  • volume remaining of the colon preparation solution [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: No ]
    Patients will be asked to bring with them to the endoscopy suit the volume remaining, if any, of the colon preparation solution that they were not able to drink. The volume remaining will be measured by the research fellow using a graduated cylinder.

  • Side effects [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: Yes ]
    number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Halls
every patient will drink 4 Liters of PEG solution (FORTRANS®) split into 2 days with sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy with Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure with Halls®).
 Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
Patients will be instructed to drink 4 Liters of PEG solution (FORTRANS®) split into 2 days while sucking on sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy while continuously sucking on Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure while continuously sucking on Halls®)
no Halls
Every patient will drink 4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)
 Other: PEG solution (Fortrans®)
4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 (NYHA class III or IV)
  • dehydration
  • severe acute inflammatory disease
  • compromised swallowing reflex or mental status
  • uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
  • toxic colitis or megacolon
  • previous colonoscopy within the last 5 years
  • active Inflammatory bowel disease
  • previous colectomy or partial colectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541683

Contacts
Contact: Ala I Sharara, MD +9611350000 ext 5345 as08@aub.edu.lb

Locations
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 1107 2020
Contact: Ala I Sharara, MD     +9611350000 ext 5345     as08@aub.edu.lb    
Contact: Mustapha M El-Halabi, MD     +9611350000 ext 5405     me69@aub.edu.lb    
Principal Investigator: Ala I Sharara, MD            
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Ala I Sharara, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Ala'a Sharara, Head and Professor, Division of Gastroenterology and Hepatology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01541683     History of Changes
Other Study ID Numbers: IM.AS1.28
Study First Received: February 21, 2012
Last Updated: January 25, 2013
Health Authority: Lebanon: Ministry of Public Health

Keywords provided by American University of Beirut Medical Center:
PEG-electrolyte solution
bowel cleansing
Mentholyptus drops
Palatability

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Menthol
Citric Acid
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013