Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NER1008 enema
Fleet
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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).
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- BioKinetic Europe Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NER1008
Fleet
Arm Description
Use of NER1008 enema for bowel cleansing
Use of Fleet enema for bowel cleansing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Grade of bowel cleansing
Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
Quality of cleansing in rectum
Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
Quality of cleansing in sigmoid colon
Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
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)
Depth of scope progression
Prior to removing the endoscope, the depth of progression it has made, in cms
Stool weight
Weight of stool during the one hour period after the administration of the enema
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02468726
Brief Title
Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
Official Title
A Clinical Investigation to Demonstrate the Performance of NER1008 Enema in Bowel Cleansing Compared to Fleet® Enema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norgine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NER1008
Arm Type
Experimental
Arm Description
Use of NER1008 enema for bowel cleansing
Arm Title
Fleet
Arm Type
Active Comparator
Arm Description
Use of Fleet enema for bowel cleansing
Intervention Type
Device
Intervention Name(s)
NER1008 enema
Intervention Description
NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
Intervention Type
Drug
Intervention Name(s)
Fleet
Intervention Description
Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
Primary Outcome Measure Information:
Title
Success of bowel cleansing
Description
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.
Time Frame
Up to 3 hours
Secondary Outcome Measure Information:
Title
Grade of bowel cleansing
Description
Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
Time Frame
Up to 3 hours
Title
Quality of cleansing in rectum
Description
Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
Time Frame
Up to 3 hours
Title
Quality of cleansing in sigmoid colon
Description
Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
Time Frame
Up to 3 hours
Title
Quality of cleansing in the descending colon
Description
Quality of cleansing in the descending colon to the splenic flexure based on the modified Harefield cleansing scale (0-4)
Time Frame
Up to 3 hours
Title
Depth of scope progression
Description
Prior to removing the endoscope, the depth of progression it has made, in cms
Time Frame
Up to 3 hours
Title
Stool weight
Description
Weight of stool during the one hour period after the administration of the enema
Time Frame
Up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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).
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Bell, MD
Organizational Affiliation
BioKinetic Europe Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
BioKinetic Europe Ltd
City
Belfast
ZIP/Postal Code
BT2 7BA
Country
United Kingdom
12. IPD Sharing Statement
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Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
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