Colorectal CancerNCT02468726
Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
A study testing NER1008 enema and Fleet in people with Colorectal Cancer, run by Norgine at 1 site in United Kingdom.
Trial summary
In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection of abnormalities. This is achieved through the use of bowel cleansing preparations, which are administered prior to the procedure. 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?
- NER1008 enema and Fleet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- 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
- Healthy male or female subjects [as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead electrocardiograms (ECG's) at screening] aged 18 to 45 years.
- Non-smokers from 3 months before enema administration and for the duration of the clinical investigation.
- Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
- Must voluntarily provide written informed consent to participate in the clinical investigation.
- Must understand the purposes and risks of the clinical investigation and agree to follow the restrictions and schedule of procedures as defined in the clinical investigation plan, and as confirmed during the informed consent process.
- Female subjects must be postmenopausal (for at least one year and confirmed by a serum follicle stimulating hormone (FSH) test at screening), surgically sterile, practising true sexual abstinence or must use an effective method of contraception.
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- Female subjects of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in of each period.
- The subject's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical investigation.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
Who cannot join
- Subjects with a history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- Subjects with a history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome, inflammatory bowel disease).
- Subjects with a clinically relevant history or presence of abnormal gastrointestinal motility.
- Subjects with a significant history of hereditary bowel disorders.
- Subjects with abnormal findings on the digital rectal examination performed at screening.
- Use of laxatives or motility altering drugs in the 3 months preceding enema administration.
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- Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 14 days prior to enema administration (or within 5 half lives if longer), with the exception of Investigator-approved hormonal contraceptives, hormone replacement therapy (HRT) and occasional paracetamol.
- Participation in a clinical drug study during the 30 days preceding enema administration in this clinical investigation.
- Donation of blood or blood products within 30 days prior to enema administration or during the clinical investigation, except as required for this clinical investigation
- Pregnant or lactating females.
- Any clinically significant illness within 28 days prior to enema administration.
- History or presence of any significant drug allergy, or a known allergy or contraindication to polyethylene glycols, Fleet® enema or midazolam.
- Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse within the 12 months prior to enema administration, or a positive drugs of abuse test at screening or check-in.
- Consumption of alcoholic beverages within 24 hours of confinement or during confinement.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the clinical investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation to Demonstrate the Performance of NER1008 Enema in Bowel Cleansing Compared to Fleet® Enema
In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection of abnormalities. This is achieved through the use of bowel cleansing preparations, which are administered prior to the procedure. Enemas are the preferred method as they clear the lower bowel more quickly than oral formulations and do not require dietary restrictions.
The medical device being tested in this clinical investigation is NER1008, an enema which contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the water content in the rectum and sigmoid colon, consequently increasing stool volume, resulting in rectal distension and subsequent distal colon emptying. The increased colonic luminal content stimulates the motility, propulsive transportation and rectal evacuation of the distal colon content.
This study is designed to assess the performance of NER1008 in bowel cleansing and compare this with the performance of Fleet® enema, which is widely used for this purpose.
- Conditions
- Colorectal Cancer
- Being tested
- NER1008 enema, Fleet
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NER1008 enemaDevice
NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
FleetDrug
Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
| Study group | Role | What they receive |
|---|---|---|
| NER1008 | Experimental | Use of NER1008 enema for bowel cleansing Receives: Device: NER1008 enema |
| Fleet | Active comparator | Use of Fleet enema for bowel cleansing Receives: Drug: Fleet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of bowel cleansing
Whether recto-sigmoid bowel cleansing has been successful, based on an endoscopist's assessment of the quality of cleansing in the rectum and colon, according to the modified Harefield cleansing scale.
Measured: Up to 3 hours
Secondary outcomes (6)
Grade of bowel cleansing
Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
Measured: Up to 3 hours
Quality of cleansing in rectum
Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
Measured: Up to 3 hours
Quality of cleansing in sigmoid colon
Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
Measured: Up to 3 hours
Quality of cleansing in the descending colon
Quality of cleansing in the descending colon to the splenic flexure based on the modified Harefield cleansing scale (0-4)
Measured: Up to 3 hours
Depth of scope progression
Prior to removing the endoscope, the depth of progression it has made, in cms
Measured: Up to 3 hours
Stool weight
Weight of stool during the one hour period after the administration of the enema
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionDec 2012
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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Bell, MD, Principal investigator, BioKinetic Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468726
- Sponsor's protocol ID
- NER1008-01/2011 (ENE)
- Status last verified
- Nov 2011
- First submitted
- 9 Jun 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Demonstrate the Performance of NER1008 Enema in Bowel Cleansing Compared to Fleet® Enema
- ClinicalTrials.gov ID
- NCT02468726
- Acronym / sponsor ID
- NER1008-01/2011 (ENE)
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jun 2015 (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.
In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection of abnormalities. This is achieved through the use of bowel cleansing preparations, which are administered prior to the procedure. Enemas are the preferred method as they clear the lower bowel more quickly than oral formulations and do not require dietary restrictions.
The medical device being tested in this clinical investigation is NER1008, an enema which contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the water content in the rectum and sigmoid colon, consequently increasing stool volume, resulting in rectal distension and subsequent distal colon emptying. The increased colonic luminal content stimulates the motility, propulsive transportation and rectal evacuation of the distal colon content.
This study is designed to assess the performance of NER1008 in bowel cleansing and compare this with the performance of Fleet® enema, which is widely used for this purpose.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NER1008 | Experimental | Device: NER1008 enemaUse of NER1008 enema for bowel cleansing |
| Fleet | Active comparator | Drug: FleetUse of Fleet enema for bowel cleansing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects [as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead electrocardiograms (ECG's) at screening] aged 18 to 45 years.
- Non-smokers from 3 months before enema administration and for the duration of the clinical investigation.
- Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
- Must voluntarily provide written informed consent to participate in the clinical investigation.
- Must understand the purposes and risks of the clinical investigation and agree to follow the restrictions and schedule of procedures as defined in the clinical investigation plan, and as confirmed during the informed consent process.
Key exclusion criteria (17 listed)
- Subjects with a history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- Subjects with a history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome, inflammatory bowel disease).
- Subjects with a clinically relevant history or presence of abnormal gastrointestinal motility.
- Subjects with a significant history of hereditary bowel disorders.
- Subjects with abnormal findings on the digital rectal examination performed at screening.
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 |
|---|---|---|
| NER1008 enemaNER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy | Device | NER1008 |
| FleetFleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy | Drug | Fleet |
Primary outcome
Success of bowel cleansing
Time frame: Up to 3 hours
Whether recto-sigmoid bowel cleansing has been successful, based on an endoscopist's assessment of the quality of cleansing in the rectum and colon, according to the modified Harefield cleansing scale.
6 secondary outcomes
Grade of bowel cleansing
Time frame: Up to 3 hours
Quality of cleansing in rectum
Time frame: Up to 3 hours
Quality of cleansing in sigmoid colon
Time frame: Up to 3 hours
Quality of cleansing in the descending colon
Time frame: Up to 3 hours
Depth of scope progression
Time frame: Up to 3 hours
Stool weight
Time frame: Up to 3 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 11 Jun 2015.
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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.
David J Bell, MD principal investigator
BioKinetic Europe Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NER1008 enema and Fleet in people with Colorectal Cancer, run by Norgine at 1 site in United Kingdom.
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 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 11 Jun 2015. 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 United Kingdom. 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.
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?
Success of bowel cleansing (time frame: Up to 3 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 11 Jun 2015.