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Completed

NCT Number: NCT01251237

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wolfgang Fischback

Aschaffenburg, D-63739, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall Acceptance on VAS (100mm) rating

    Time frame: 12 hours

Secondary outcomes

  1. Tolerance on five-point VRS

    Time frame: 12 hours

  2. Taste Evaluation on VAS (100mm) rating

    Time frame: 12 hours

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

    Time frame: 12 hours

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

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Norgine

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2010
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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