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:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT01251237
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance on five-point VRS [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Taste Evaluation on VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Acceptability rated by compliance, four-point VRS and VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Efficacy on five-grade scale for pre-defined colon areas [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251237

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

No publications provided

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
Study First Received: November 30, 2010
Last Updated: November 30, 2010
Health Authority: Germany: Ministry of Health

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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014