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Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251237
First Posted: December 1, 2010
Last Update Posted: December 1, 2010
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.
Information provided by:
Norgine
  Purpose

It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.

Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.


Condition Intervention Phase
Colon Cancer Drug: NRL0706 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open Study to Assess the Tolerability, Safety and Efficacy of an Adapted 2 Litre Gut Cleansing Solution (NRL0706) in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumour Screening.

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Overall Acceptance on VAS (100mm) rating [ Time Frame: 12 hours ]

Secondary Outcome Measures:
  • Tolerance on five-point VRS [ Time Frame: 12 hours ]
  • Taste Evaluation on VAS (100mm) rating [ Time Frame: 12 hours ]
  • Acceptability rated by compliance, four-point VRS and VAS (100mm) rating [ Time Frame: 12 hours ]
  • Efficacy on five-grade scale for pre-defined colon areas [ Time Frame: 12 hours ]

Enrollment: 120
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moviprep Orange
All patients receive 2 litres of NRL0706 solution.
Drug: NRL0706
Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject's written informed consent must be obtained prior to inclusion.
  • Male or female ambulatory subjects aged between 40 to 75 years undergoing a complete colonoscopy for colon cancer screening.
  • No history of significant gastrointestinal diseases, including gastrointestinal obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
  • Willing to undergo a colonoscopy for colon cancer screening.
  • Willing, able and competent to complete the entire procedure and to comply with study instructions.
  • Females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

  • History of gastric emptying disorders
  • History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation
  • History of Phenylketonuria
  • Known Glucose-6-phosphate dehydrogenase deficiency
  • Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/ sodium ascorbate
  • History of colonic resection
  • Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
  • Presence of congestive heart failure (NYHA III + IV)
  • Acute life-threatening cardiovascular disease
  • Documented history of severe renal insufficiency
  • Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months
  • Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
  • Subjects who the investigator feels would not be compliant with the requirements of the trial
  Contacts and Locations
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): NCT01251237


Locations
Germany
Wolfgang Fischback
Aschaffenburg, Germany, D-63739
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Wolfgang Fischbach, Prof Dr med Klinikum Aschaffenburg-Alzenau
  More Information

Responsible Party: Vice President, Clinical Development, Norgine
ClinicalTrials.gov Identifier: NCT01251237     History of Changes
Other Study ID Numbers: NRL0706-01/2009 (VOM)
2009-014845-95 ( EudraCT Number )
First Submitted: November 30, 2010
First Posted: December 1, 2010
Last Update Posted: December 1, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Pharmaceutical Solutions