Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
This study has been completed.
Sponsor:
Norgine
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT01251237
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: NRL0706 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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. |
Resource links provided by NLM:
Further study details as provided by Norgine:
Primary Outcome Measures:
- Overall Acceptance on VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerance on five-point VRS [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Taste Evaluation on VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Acceptability rated by compliance, four-point VRS and VAS (100mm) rating [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Efficacy on five-grade scale for pre-defined colon areas [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moviprep Orange
All patients receive 2 litres of NRL0706 solution.
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vice President, Clinical Development, Norgine |
| ClinicalTrials.gov Identifier: | NCT01251237 History of Changes |
| Other Study ID Numbers: | NRL0706-01/2009 (VOM), 2009-014845-95 |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 30, 2010 |
| Health Authority: | Germany: Ministry of Health |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013