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

NCT01251237 | Completed Phase 2

• 2 other identifiers: NRL0706-01/2009 (VOM)2009-014845-95
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Acceptance on VAS (100mm) rating

  12 hours

Secondary Outcomes (4)

• Tolerance on five-point VRS

  12 hours

• Taste Evaluation on VAS (100mm) rating

  12 hours

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

  12 hours

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

  12 hours

Study Arms (1)

Moviprep Orange

EXPERIMENTAL

All patients receive 2 litres of NRL0706 solution.

Drug: NRL0706

Interventions

NRL0706 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.

Moviprep Orange

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Wolfgang Fischback

Aschaffenburg, D-63739, Germany

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Wolfgang Fischbach, Prof Dr med

  Klinikum Aschaffenburg-Alzenau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

DE (1)