ColonoscopyPhase 3NCT00427089
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
A Phase 3 study testing Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate and Sodium Phosphate solution (NaP) in people with Colonoscopy, run by Norgine at 12 sites in Germany.
Trial summary
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate and Sodium Phosphate solution (NaP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 12 sitesGermany
- Study dates
- Sep 2004to May 2005
- Phase
- Phase 3
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject's written informed consent had to be obtained prior to inclusion.
- Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
- Willing, able and competent to complete the entire procedure and to comply with study instructions
- Females of childbearing potential had to employ an adequate method of contraception
Who cannot join
- Ileus
- Intestinal obstruction or perforation
- Toxic megacolon
- History of colonic resection
- Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
- Congestive heart failure (NYHA III + IV)
Show all 17Show fewer
- Acute life threatening cardiovascular disease
- Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
- Known moderate to severe renal insufficiency
- Severe renal failure
- Severe liver failure
- Known glucose 6 phosphatase dehydrogenase deficiency
- Known phenylketonuria
- Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
- Concurrent participation in an investigational drug study or participation within 30 days of study entry
- Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
- Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Klinikum Aschaffenburg Am Hasenkopf 1
Aschaffenburg, Bavaria, 63739
Schiessgrabenstr. 34
Augsburg, Bavaria, 86150
Dieburger Str. 29
Darmstadt, Hesse, 64287
Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
Erfurt, Thuringia, 99097
Spardorfer Str. 39
Erlangen, Bavaria, 91054
Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
Hamburg, Free and Hanseatic City of Hamburg, 22297
Heiligengrabstr. 22
Hof, Bavaria, 95028
Rätestr. 20
Kirchheim, Bavaria, 85551
Erzbergstr. 113
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Uferstr. 3
Minden, Westfalen-Lippe, 32423
Unter den Eichen 26
Oldenburg, Lower Saxony, 26122
Sternbergstr. 8
Regensburg, Bavaria, 93047
About this study
Official title: Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
Read the detailed description
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
- Conditions
- Colonoscopy
- Being tested
- Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate, Sodium Phosphate solution (NaP)
- Keywords
- Colon cleansing, Polyethylene Glycol, Sodium Phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na AscorbateDrug
Also called MOVIPREP®
2L gut lavage solution
Sodium Phosphate solution (NaP)Drug
45 ml solution; BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2L gut cleansing solution Receives: Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate |
| 2 | Active comparator | Not described Receives: Drug: Sodium Phosphate solution (NaP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
Secondary outcomes (6)
the "overall" judgment of the investigator for the colon preparation was documented.
Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
The taste of the solutions was assessed.
Acceptability and tolerance for the subject was compared.
All Adverse Events were recorded to evaluate the safety.
Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startSep 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Ell, Prof Dr med, Principal investigator, Dr. Horst Schmidt Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427089
- Sponsor's protocol ID
- NRL 994-01/2004 (HSG)
- Status last verified
- Apr 2008
- First submitted
- 25 Jan 2007
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ell C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18
Ell C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23.
PubMed 25180609
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.
- ClinicalTrials.gov ID
- NCT00427089
- Acronym / sponsor ID
- NRL 994-01/2004 (HSG)
- Conditions
- Colonoscopy
- Keywords
- Colon cleansing, Polyethylene Glycol, Sodium Phosphate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- May 2005
- First posted
- 26 Jan 2007 (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.
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
Detailed description
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate2L gut cleansing solution |
| 2 | Active comparator | Drug: Sodium Phosphate solution (NaP) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject's written informed consent had to be obtained prior to inclusion.
- Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
- Willing, able and competent to complete the entire procedure and to comply with study instructions
- Females of childbearing potential had to employ an adequate method of contraception
Key exclusion criteria (17 listed)
- Ileus
- Intestinal obstruction or perforation
- Toxic megacolon
- History of colonic resection
- Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
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 |
|---|---|---|
| Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na AscorbateAlso: MOVIPREP®2L gut lavage solution | Drug | 1 |
| Sodium Phosphate solution (NaP)45 ml solution; BID | Drug | 2 |
Primary outcome
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
6 secondary outcomes
the "overall" judgment of the investigator for the colon preparation was documented.
Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
The taste of the solutions was assessed.
Acceptability and tolerance for the subject was compared.
All Adverse Events were recorded to evaluate the safety.
Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.
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 16 Apr 2008.
- Results publicationEll C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18
- Derived from this study: PubMed 25180609Ell C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23.
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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.
Christian Ell, Prof Dr med principal investigator
Dr. Horst Schmidt Kliniken GmbH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate and Sodium Phosphate solution (NaP) in people with Colonoscopy, run by Norgine at 12 sites 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 4 inclusion and 17 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 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427089, which also lists 2 linked publications.
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 16 Apr 2008.