- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468726
Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Belfast, United Kingdom, BT2 7BA
- BioKinetic Europe Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NER1008
Use of NER1008 enema for bowel cleansing
|
NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
|
Active Comparator: Fleet
Use of Fleet enema for bowel cleansing
|
Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade of bowel cleansing
Time Frame: Up to 3 hours
|
Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
|
Up to 3 hours
|
Quality of cleansing in rectum
Time Frame: Up to 3 hours
|
Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
|
Up to 3 hours
|
Quality of cleansing in sigmoid colon
Time Frame: Up to 3 hours
|
Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
|
Up to 3 hours
|
Quality of cleansing in the descending colon
Time Frame: Up to 3 hours
|
Quality of cleansing in the descending colon to the splenic flexure based on the modified Harefield cleansing scale (0-4)
|
Up to 3 hours
|
Depth of scope progression
Time Frame: Up to 3 hours
|
Prior to removing the endoscope, the depth of progression it has made, in cms
|
Up to 3 hours
|
Stool weight
Time Frame: Up to 3 hours
|
Weight of stool during the one hour period after the administration of the enema
|
Up to 3 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David J Bell, MD, BioKinetic Europe Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NER1008-01/2011 (ENE)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on NER1008 enema
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Chiang Mai UniversityPrapaporn SuprasertCompletedOther Surgical Procedures | Cathartic ColonThailand
-
London North West Healthcare NHS TrustCompletedAnastomotic Leak | Ulcerative Colitis | Ileal PouchUnited Kingdom
-
Nabiqasim Industries (Pvt) LtdDow University of Health SciencesUnknownIrritable Bowel SyndromePakistan
-
Johns Hopkins UniversityUniversity of California, Los AngelesCompleted
-
Illinois Urogynecology, Ltd.UnknownColon CleansingUnited States
-
McMaster Children's HospitalLondon Health Sciences Centre; St. Justine's HospitalCompletedUlcerative Colitis | Inflammatory Bowel DiseaseCanada
-
PurGenesis Technologies Inc.CompletedUlcerative ColitisGermany
-
University of British ColumbiaCrohn's and Colitis CanadaWithdrawnInflammatory Bowel Diseases | Ulcerative ColitisCanada
-
Children's Hospital Los AngelesTerminatedFunctional ConstipationUnited States