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

NCT ID: NCT01251237

Last Updated: 2010-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Moviprep Orange

All patients receive 2 litres of NRL0706 solution.

Group Type: EXPERIMENTAL

NRL0706

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Norgine

Principal Investigators

Wolfgang Fischbach, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Klinikum Aschaffenburg-Alzenau

Locations

Wolfgang Fischback

Aschaffenburg, , Germany

Countries

Germany

Other Identifiers

2009-014845-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NRL0706-01/2009 (VOM)

Identifier Type: -

Identifier Source: org_study_id