Colorectal CancerPhase 2NCT06597903
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
A Phase 2 study testing NRL994 in people with Colorectal Cancer, run by Norgine at 1 site in Germany.
Trial summary
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- NRL994
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2001to Mar 2002
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent must be obtained prior to inclusion
- Male or female
- Inpatients 18 to 60 years old with indication for complete colonoscopy
- Willing and able 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
- Ileus
- Intestinal obstruction or perforation.
- Toxic megacolon.
- History of any colonic surgery.
- Cardiac Insufficiency (NYHA grad III and IV).
- Ischemic cardio vascular disease.
Show all 14Show fewer
- Renal insufficiency (creatinine above 1.4 mg/100 ml).
- Cirrhosis of liver (child B or C).
- Known hypersensitivity to polyethylene glycols and/or Vitamin C.
- Concurrent participation in an investigational drug study or participation within 30 days of study entry.
- Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
- Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
- Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmgH).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.
Read the detailed description
A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy.
The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure.
A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g).
Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.
- Conditions
- Colorectal Cancer
- Being tested
- NRL994
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL994Drug
Also called Low dose bowel prep (LDBP), MOVIPREP
In the afternoon/evening before colonoscopy: 1 litre solution plus 0.5 litre clear fluid.
Day of colonoscopy: 1 litre solution plus at least up to 1 litre clear liquid.
| Study group | Role | What they receive |
|---|---|---|
| NRL994 low dose bowel prep (LDBP) | Experimental | Patients given two doses of NRL994, one on the evening before and one on the morning of their scheduled colonoscopy. Degree of gut cleansing was rated by the colonoscopist and an independent reviewer. Volume of fluid aspirated during colonoscopy and weight of stools/volume of urine from start of cleansing to start of colonoscopy were also measured. Number of patients who reached clear effluent evaluated. Receives: Drug: NRL994 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of gut cleansing
Degree of gut cleansing in each of five predefined gut segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon) rated on a 5-level verbal rating scale (VRS) ranging from 4 (very good) to 0 (very bad) by
- the physician performing the endoscopic procedure and
- by an independent reviewer on the basis of video tapes registered during colonoscopy.
Measured: Day 0 during colonoscopy
Overall quality of colonic cleansing
Overall quality of colonic cleansing as rated on a 3-level VRS with ranks:
A = very good or good colon cleansing in all five gut segments, B = at least one colon segment with moderate or bad cleansing result, C = very bad cleansing result in at least one colon segment.
Measured: Day 0 during colonoscopy
Physicians overall judgement of colon preparation
Physicians overall judgement of colon preparation as assessed on a 5-level VRS ranging from very good to very bad.
Measured: Day 0 during colonoscopy
Volume of fluid aspirated (ml)
Volume of fluid aspirated from intestinal lumen during colonoscopy.
Measured: Day 0 during colonoscopy
Stool and urine weight (g)
Weight of stools and urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Measured: Day -1 and Day 0 prior to colonoscopy.
Clear effluent
Number of patients in whom a clear effluent (containing no residual faecal material) was obtained.
Measured: Day -1 and Day 0 prior to colonoscopy.
Patient satisfaction - convenience
Patients overall judgement of convenience of use of LDBP as assessed in the CRF on a on a 5-level VRS ranging from 4 (very good) to 0 (very bad).
Measured: Day -1 and Day 0 prior to colonoscopy
Patient satisfaction - taste
Patients overall judgement of the taste of LDBP as assessed in the CRF on a on a VAS ranging from 0 (very bad) to 100 mm (very good).
Measured: Day -1 and Day 0 prior to colonoscopy
Secondary outcomes (8)
Adverse events
- Occurrence of adverse events;
Measured: Day -1 and Day 0 prior to colonoscopy
Global tolerance
Physicians global assessment of tolerability of LDBP as rated on a 4-level VRS ranging from (excellent) to (bad).
Measured: Day -1 and Day 0 prior to colonoscopy
Hematology
A blood sample was obtained for hematology (hematocrit, hemoglobin, red and white blood cell count, platelet count) at baseline and after intake of the second dose of LDBP just before colonoscopy.
Measured: Day -2 to Day 0 prior to colonoscopy
Serum chemistry
A blood sample was obtained for serum chemistry (electrolytes [sodium, potassium, chloride, bicarbonate], liver enzymes [ASAT, ALAT], total protein, blood urea nitrogen [BUN], creatinine, Quick time) at baseline and after intake of the second dose of LDBP just before colonoscopy.
Measured: Day -2 to Day 0 prior to colonoscopy
Urine electrolytes
Amount of electrolytes (sodium, potassium, calcium) excreted in urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Measured: Day -1 to Day 0 prior to colonoscopy
Blood pressure (mmHg)
Blood pressure was measured at baseline, upon completion of LDBP intake, and after the end of colonoscopy.
Measured: Day -2 to Day 0 after colonoscopy
Pulse rate (bpm)
Pulse rate in beats per minute (bpm) was measured at baseline, upon completion of LDBP intake, and after the end of colonoscopy.
Measured: Day -2 to Day 0 after colonoscopy
Body weight (kg)
Actual body weight in kilograms (kg) was measured before and after the administration of LDBP.
Measured: Day -1 prior to LDBP and Day 0 prior to colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startMay 2001
- Primary completionMar 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- K-J Goerg, PD Dr. med., Principal investigator, Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597903
- Sponsor's protocol ID
- NRL994-01/2000
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
- ClinicalTrials.gov ID
- NCT06597903
- Acronym / sponsor ID
- NRL994-01/2000
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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.
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.
Detailed description
A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy.
The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure.
A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g).
Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRL994 low dose bowel prep (LDBP) | Experimental | Drug: NRL994Patients given two doses of NRL994, one on the evening before and one on the morning of their scheduled colonoscopy. Degree of gut cleansing was rated by the colonoscopist and an independent reviewer. Volume of fluid aspirated during colonoscopy and weight of stools/volume of urine from start of cleansing to start of colonoscopy were also measured. Number of patients who reached clear effluent evaluated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained prior to inclusion
- Male or female
- Inpatients 18 to 60 years old with indication for complete colonoscopy
- Willing and able to complete the entire procedure and to comply with study instructions
- Females of childbearing potential must employ an adequate method of contraception.
Key exclusion criteria (14 listed)
- Ileus
- Intestinal obstruction or perforation.
- Toxic megacolon.
- History of any colonic surgery.
- Cardiac Insufficiency (NYHA grad III and IV).
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 |
|---|---|---|
| NRL994Also: Low dose bowel prep (LDBP), MOVIPREPIn the afternoon/evening before colonoscopy: 1 litre solution plus 0.5 litre clear fluid. Day of colonoscopy: 1 litre solution plus at least up to 1 litre clear liquid. | Drug | NRL994 low dose bowel prep (LDBP) |
Primary outcome
Degree of gut cleansing
Time frame: Day 0 during colonoscopy
Degree of gut cleansing in each of five predefined gut segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon) rated on a 5-level verbal rating scale (VRS) ranging from 4 (very good) to 0 (very bad) by 1. the physician performing the endoscopic procedure and 2. by an independent reviewer on the basis of video tapes registered during colonoscopy.
Overall quality of colonic cleansing
Time frame: Day 0 during colonoscopy
Overall quality of colonic cleansing as rated on a 3-level VRS with ranks: A = very good or good colon cleansing in all five gut segments, B = at least one colon segment with moderate or bad cleansing result, C = very bad cleansing result in at least one colon segment.
Physicians overall judgement of colon preparation
Time frame: Day 0 during colonoscopy
Physicians overall judgement of colon preparation as assessed on a 5-level VRS ranging from very good to very bad.
Volume of fluid aspirated (ml)
Time frame: Day 0 during colonoscopy
Volume of fluid aspirated from intestinal lumen during colonoscopy.
Stool and urine weight (g)
Time frame: Day -1 and Day 0 prior to colonoscopy.
Weight of stools and urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Clear effluent
Time frame: Day -1 and Day 0 prior to colonoscopy.
Number of patients in whom a clear effluent (containing no residual faecal material) was obtained.
Patient satisfaction - convenience
Time frame: Day -1 and Day 0 prior to colonoscopy
Patients overall judgement of convenience of use of LDBP as assessed in the CRF on a on a 5-level VRS ranging from 4 (very good) to 0 (very bad).
Patient satisfaction - taste
Time frame: Day -1 and Day 0 prior to colonoscopy
Patients overall judgement of the taste of LDBP as assessed in the CRF on a on a VAS ranging from 0 (very bad) to 100 mm (very good).
8 secondary outcomes
Adverse events
Time frame: Day -1 and Day 0 prior to colonoscopy
Global tolerance
Time frame: Day -1 and Day 0 prior to colonoscopy
Hematology
Time frame: Day -2 to Day 0 prior to colonoscopy
Serum chemistry
Time frame: Day -2 to Day 0 prior to colonoscopy
Urine electrolytes
Time frame: Day -1 to Day 0 prior to colonoscopy
Blood pressure (mmHg)
Time frame: Day -2 to Day 0 after colonoscopy
Pulse rate (bpm)
Time frame: Day -2 to Day 0 after colonoscopy
Body weight (kg)
Time frame: Day -1 prior to LDBP and Day 0 prior to colonoscopy.
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 19 Sep 2024.
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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.
K-J Goerg, PD Dr. med. principal investigator
Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany
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 NRL994 in people with Colorectal 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 5 inclusion and 14 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 19 Sep 2024. 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?
Degree of gut cleansing (time frame: Day 0 during colonoscopy). The study lists 8 primary outcomes in all. 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 19 Sep 2024.