Colon CancerPhase 2NCT01251237
Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
A Phase 2 study testing NRL0706 in people with Colon Cancer, run by Norgine at 1 site in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- NRL0706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- NRL0706
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL0706Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Moviprep Orange | Experimental | All patients receive 2 litres of NRL0706 solution. Receives: Drug: NRL0706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Acceptance on VAS (100mm) rating
Measured: 12 hours
Secondary outcomes (4)
Tolerance on five-point VRS
Measured: 12 hours
Taste Evaluation on VAS (100mm) rating
Measured: 12 hours
Acceptability rated by compliance, four-point VRS and VAS (100mm) rating
Measured: 12 hours
Efficacy on five-grade scale for pre-defined colon areas
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Fischbach, Prof Dr med, Principal investigator, Klinikum Aschaffenburg-Alzenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251237
- Sponsor's protocol ID
- NRL0706-01/2009 (VOM)
- Other IDs
- 2009-014845-95, 2009
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01251237
- Acronym / sponsor ID
- NRL0706-01/2009 (VOM)
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moviprep Orange | Experimental | Drug: NRL0706All patients receive 2 litres of NRL0706 solution. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRL0706Patients 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. | Drug | Moviprep Orange |
Primary outcome
Overall Acceptance on VAS (100mm) rating
Time frame: 12 hours
4 secondary outcomes
Tolerance on five-point VRS
Time frame: 12 hours
Taste Evaluation on VAS (100mm) rating
Time frame: 12 hours
Acceptability rated by compliance, four-point VRS and VAS (100mm) rating
Time frame: 12 hours
Efficacy on five-grade scale for pre-defined colon areas
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Fischbach, Prof Dr med principal investigator
Klinikum Aschaffenburg-Alzenau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRL0706 in people with Colon Cancer, run by Norgine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Acceptance on VAS (100mm) rating (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.