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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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

NRL0706

About this trial

This is an interventional diagnostic trial for Colon Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wolfgang Fischback

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moviprep Orange

Arm Description

All patients receive 2 litres of NRL0706 solution.

Outcomes

Primary Outcome Measures

Overall Acceptance on VAS (100mm) rating

Secondary Outcome Measures

Tolerance on five-point VRS

Taste Evaluation on VAS (100mm) rating

Acceptability rated by compliance, four-point VRS and VAS (100mm) rating

Efficacy on five-grade scale for pre-defined colon areas

Full Information

NCT ID

NCT01251237

First Posted

November 30, 2010

Last Updated

November 30, 2010

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT01251237

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moviprep Orange

Arm Type

Experimental

Arm Description

All patients receive 2 litres of NRL0706 solution.

Intervention Type

Drug

Intervention Name(s)

NRL0706

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Acceptance on VAS (100mm) rating

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

Tolerance on five-point VRS

Time Frame

12 hours

Title

Taste Evaluation on VAS (100mm) rating

Time Frame

12 hours

Title

Acceptability rated by compliance, four-point VRS and VAS (100mm) rating

Time Frame

12 hours

Title

Efficacy on five-grade scale for pre-defined colon areas

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Fischbach, Prof Dr med

Organizational Affiliation

Klinikum Aschaffenburg-Alzenau

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wolfgang Fischback

City

Aschaffenburg

ZIP/Postal Code

D-63739

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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