Colon CancerPhase 2NCT01714466
Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy
A Phase 2 study testing NER1006 and MOVIPREP in people with Colon Cancer, run by Norgine at 2 sites in Germany.
Trial summary
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®) Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- NER1006 and MOVIPREP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2012to Jan 2014
- 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 40 to 70 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.
- Subjects age 40 to 70 years.
- Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:
- is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or
- is aged 55 to 70.
- Part A: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
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- Females of child bearing potential must be surgically sterile, post- menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
- Ferrous sulphate should be stopped at least one week prior to study medication.
Who cannot join
- Part A only: Subjects undergoing screening colonoscopy.
- Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
- Regular use of laxatives or colon motility altering drugs in the last month.
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
- Known glucose-6-phosphatase dehydrogenase deficiency.
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- Known phenylketonuria.
- History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
- Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
- Evidence of dehydration.
- Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
- Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
- Clinically relevant findings on physical examination based on the Investigator's judgement.
- Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
- Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
- Subjects who are unwilling to comply with the provisions of the study protocol.
- Concurrent participation in an investigational drug study or participation within 3 months of study entry.
- Subject has a condition or is in a situation, which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- Previous participation in the study.
- Persons who are ordered to live in an institution on court or authority order
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
PAREXEL International Early Product Development Unit
Berlin, 14050
Parexel International GmbH
Berlin, 14050
About this study
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
- Conditions
- Colon Cancer
- Being tested
- NER1006, MOVIPREP
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NER1006Drug
MOVIPREPDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A, arm 1 | Experimental | Evening dose of TF048. Morning dose of TF043 Receives: Drug: NER1006 |
| Part A, arm 2 | Experimental | Evening dose of TF043. Morning dose of TF048 Receives: Drug: NER1006 |
| Part A, arm 3 | Experimental | Evening dose of TF047. Morning dose of TF043 Receives: Drug: NER1006 |
| Part A, arm 4 | Active comparator | MOVIPREP (Both evening and morning dose) Receives: Drug: MOVIPREP |
| Part B, arm 1 | Experimental | IMP selected based on the optimal dosing sequence and volume identified from Part A Receives: Drug: NER1006 |
| Part B, arm 2 | Experimental | IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed Receives: Drug: NER1006 |
| Part B, arm 3 | Active comparator | IMP as used in Part B, arm 1, except for a reduced amount of ascorbate Receives: Drug: NER1006 |
| Part B, arm 4 | Experimental | MOVIPREP used in both evening and morning dose Receives: Drug: MOVIPREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool weight output
Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours
Measured: 36 hours post-dose
Cleansing success rate
The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
Measured: 36 hours post-dose
Secondary outcomes (7)
Tolerability of medication (vomiting rate)
The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B
Measured: 36 hours post-dose
EQ 5D patient questionnaire outcome (Part A only)
Patients to use the EQ 5D patient questionnaire to assess their study medication for part A
Measured: 36 hours post-dose
Cleansing scores for each colon segment
The segmental cleansing scores for each of the five colon segments
Measured: 36 hours post-dose
Time and volume of IMP to reach a clear effluent
The time and volume taken for the IMP to reach a clear effluent
Measured: 36 hours post-dose
Ascorbate concentration
Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)
Measured: 36 hours post-dose
Electrolytes concentration
Concentration of electrolytes in blood, urine and faeces
Measured: 36 hours post-dose
PEG3350 concentration
Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities
Measured: 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rudiger Kornberger, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714466
- Sponsor's protocol ID
- NER1006-01/2012 (OPT)
- Status last verified
- Nov 2014
- First submitted
- 19 Oct 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Clayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y.
PubMed 31146679
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT01714466
- Acronym / sponsor ID
- NER1006-01/2012 (OPT)
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Oct 2012 (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.
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A, arm 1 | Experimental | Drug: NER1006Evening dose of TF048. Morning dose of TF043 |
| Part A, arm 2 | Experimental | Drug: NER1006Evening dose of TF043. Morning dose of TF048 |
| Part A, arm 3 | Experimental | Drug: NER1006Evening dose of TF047. Morning dose of TF043 |
| Part A, arm 4 | Active comparator | Drug: MOVIPREPMOVIPREP (Both evening and morning dose) |
| Part B, arm 1 | Experimental | Drug: NER1006IMP selected based on the optimal dosing sequence and volume identified from Part A |
| Part B, arm 2 | Experimental | Drug: NER1006IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed |
| Part B, arm 3 | Active comparator | Drug: NER1006IMP as used in Part B, arm 1, except for a reduced amount of ascorbate |
| Part B, arm 4 | Experimental | Drug: MOVIPREPMOVIPREP used in both evening and morning dose |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject's written informed consent must be obtained prior to inclusion.
- Subjects age 40 to 70 years.
- Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:
- Part A: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- Females of child bearing potential must be surgically sterile, post- menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
Key exclusion criteria (22 listed)
- Part A only: Subjects undergoing screening colonoscopy.
- Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
- Regular use of laxatives or colon motility altering drugs in the last month.
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
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 |
|---|---|---|
| NER1006 | Drug | Part A, arm 1, Part A, arm 2, Part A, arm 3, Part B, arm 1, Part B, arm 2, Part B, arm 3 |
| MOVIPREP | Drug | Part A, arm 4, Part B, arm 4 |
Primary outcome
Stool weight output
Time frame: 36 hours post-dose
Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours
Cleansing success rate
Time frame: 36 hours post-dose
The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
7 secondary outcomes
Tolerability of medication (vomiting rate)
Time frame: 36 hours post-dose
EQ 5D patient questionnaire outcome (Part A only)
Time frame: 36 hours post-dose
Cleansing scores for each colon segment
Time frame: 36 hours post-dose
Time and volume of IMP to reach a clear effluent
Time frame: 36 hours post-dose
Ascorbate concentration
Time frame: 36 hours post-dose
Electrolytes concentration
Time frame: 36 hours post-dose
PEG3350 concentration
Time frame: 36 hours post-dose
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 20 Nov 2014.
- Derived from this study: PubMed 31146679Clayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y.
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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.
Rudiger Kornberger, MD principal investigator
Parexel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NER1006 and MOVIPREP in people with Colon Cancer, run by Norgine at 2 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 9 inclusion and 22 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Stool weight output (time frame: 36 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT01714466, which also lists 1 linked publication.
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 20 Nov 2014.