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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.


Phase 2
45 Years
75 Years
Not Enrolling
Both
Colon Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall Acceptance on VAS (100mm) rating

Outcome Time Frame:

12 hours

Safety Issue:

No

Principal Investigator

Wolfgang Fischbach, Prof Dr med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum Aschaffenburg

Authority:

Germany: Ministry of Health

Study ID:

NRL0706-01/2009 (VOM)

NCT ID:

NCT01251237

Start Date:

March 2010

Completion Date:

July 2010

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms

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