Colorectal CancerPhase 1OUTNCT01834742
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects
A Phase 1 study testing NER1006 and Moviprep in people with Colorectal Cancer, run by Norgine at 2 sites in Romania.
Trial summary
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- NER1006 and Moviprep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesRomania
- Study dates
- Apr 2011to Dec 2011
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject's written informed consent must be obtained prior to inclusion.
- Healthy subjects with an age of 18 to 45 years.
- Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, 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. 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.
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
Who cannot join
- Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
- Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
- Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
- History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
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- Known glucose-6-phosphatase dehydrogenase deficiency.
- Known phenylketonuria.
- History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
- Evidence of dehydration.
- Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
- Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
- Clinically relevant findings on physical examination based on 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 month of study entry.
- 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.
- Previous participation in the study.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Pierrel Research HP-RO-SRL
Timișoara, 300244
Pierrel Research HP-RO-SRL
Timișoara
About this study
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
- Conditions
- Colorectal Cancer
- Being tested
- NER1006, Moviprep
- Keywords
- Moviprep, PEG3350, Laxative, Stool Output
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NER1006Drug
Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
NER1006Drug
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
NER1006Drug
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
MoviprepDrug
Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
NER1006Drug
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
NER1006Drug
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
NER1006Drug
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
NER1006Drug
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
| Study group | Role | What they receive |
|---|---|---|
| Part A, arm 1 | Experimental | Evening dose 1 plus fixed morning dose Receives: Drug: NER1006 |
| Part A, arm 2 | Experimental | Evening dose 2 plus fixed morninf does Receives: Drug: NER1006 |
| Part A, arm 3 | Experimental | Evening dose 3 plus fixed morning dose Receives: Drug: NER1006 |
| Part A, arm 4 | Active comparator | Moviprep Receives: Drug: Moviprep |
| Part B, arm 1 | Experimental | Fixed evening dose plus morning dose 1 Receives: Drug: NER1006 |
| Part B, arm 2 | Experimental | Fixed evening dose plus morning dose 2 Receives: Drug: NER1006 |
| Part B, arm 3 | Experimental | Fixed evening dose plus morning dose 3 Receives: Drug: NER1006 |
| Part B, arm 4 | Experimental | Fixed evening dose plus alternative morning dose Receives: Drug: NER1006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Variable
Stool weight output generated from the start of intake for the following 24 hours.
Measured: 36 Hours
Secondary outcomes (5)
PEG3350 concentration
Concentration of PEG3350 in blood, urine and faeces.
Measured: 96 Hours
Sulphate concentration
Concentration of PEG3350 in blood, urine and faeces.
Measured: 96 hours
Ascorbic acid concentration
Concentration of ascorbic acid in blood, urine and faeces.
Measured: 96 hours
Electrolytes concentration
Concentration of electrolytes in blood, urine and faeces.
Measured: 96 hours
Safety profile
Spontaneouly reported adverse events will be recorded throughout the study
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionDec 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pierrel Research Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Rodica Cinca, MD, Principal investigator, Pierrel Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834742
- Sponsor's protocol ID
- NER1006-01/2011 (OUT)
- Acronym
- OUT
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2013
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01834742
- Acronym / sponsor ID
- OUT / NER1006-01/2011 (OUT)
- Conditions
- Colorectal Cancer
- Keywords
- Moviprep, PEG3350, Laxative, Stool Output
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Collaborators
- Pierrel Research Europe GmbH
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Apr 2013 (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.
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of 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 1 plus fixed morning dose |
| Part A, arm 2 | Experimental | Drug: NER1006Evening dose 2 plus fixed morninf does |
| Part A, arm 3 | Experimental | Drug: NER1006Evening dose 3 plus fixed morning dose |
| Part A, arm 4 | Active comparator | Drug: MoviprepMoviprep |
| Part B, arm 1 | Experimental | Drug: NER1006Fixed evening dose plus morning dose 1 |
| Part B, arm 2 | Experimental | Drug: NER1006Fixed evening dose plus morning dose 2 |
| Part B, arm 3 | Experimental | Drug: NER1006Fixed evening dose plus morning dose 3 |
| Part B, arm 4 | Experimental | Drug: NER1006Fixed evening dose plus alternative morning dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject's written informed consent must be obtained prior to inclusion.
- Healthy subjects with an age of 18 to 45 years.
- Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, 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. 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.
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
Key exclusion criteria (22 listed)
- Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
- Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
- Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
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 |
|---|---|---|
| NER1006Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. | Drug | Part A, arm 1 |
| NER1006Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. | Drug | Part A, arm 2 |
| NER1006Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. | Drug | Part A, arm 3 |
| MoviprepReconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning. | Drug | Part A, arm 4 |
| NER1006Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate. | Drug | Part B, arm 1 |
| NER1006Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate. | Drug | Part B, arm 2 |
| NER1006Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate. | Drug | Part B, arm 3 |
| NER1006Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid. | Drug | Part B, arm 4 |
Primary outcome
Primary Variable
Time frame: 36 Hours
Stool weight output generated from the start of intake for the following 24 hours.
5 secondary outcomes
PEG3350 concentration
Time frame: 96 Hours
Sulphate concentration
Time frame: 96 hours
Ascorbic acid concentration
Time frame: 96 hours
Electrolytes concentration
Time frame: 96 hours
Safety profile
Time frame: 96 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 18 Apr 2013.
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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.
Rodica Cinca, MD principal investigator
Pierrel Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NER1006 and Moviprep in people with Colorectal Cancer, run by Norgine at 2 sites in Romania.
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 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 18 Apr 2013. 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 Romania. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Primary Variable (time frame: 36 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 18 Apr 2013.