ColonoscopyPhase 1NCT01715272
A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema
A Phase 1 study testing TF037 and Fleet enema in people with Colonoscopy, run by Norgine at 2 sites in United Kingdom.
Trial summary
This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- TF037 and Fleet enema
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2012to Jan 2013
- 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 60 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 (ECGs) at screening] aged 18 to 60 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, aspirin or ibuprofen.
- 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 trisodium citrate, 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 check-inor during confinement.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the clinical investigation.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
BioKinetic Europe Ltd
Belfast, Northern Ireland, BT2 7BA
BioKinetic Europe Ltd
Belfast
About this study
This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing.
- Conditions
- Colonoscopy
- Being tested
- TF037, Fleet enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF037Device
Fleet enemaDrug
| Study group | Role | What they receive |
|---|---|---|
| Fleet enema | Active comparator | This group will receive Fleet enema as their treatment Receives: Drug: Fleet enema |
| TF037 | Experimental | This group will receive TF037 as their treatment Receives: Device: TF037 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale
Measured: Between 1 to 3 hours following enema administration
Secondary outcomes (3)
Stool output as measured by stool weight
To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema
Measured: up to 1 hour following enema administration
Safety and tolerability as assessed by use of a Visual Analogue scale (VAS)
To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose
Measured: 5 and 30 minutes following enema administration
Stool output over time
To assess kinetics of bowel movements in relation to stool output over time
Measured: 1 hour following enema administration
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 completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronnie Beboso, MD, Principal investigator, BioKinetic Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715272
- Sponsor's protocol ID
- NER1008-01/2012 (DBC)
- Status last verified
- Feb 2013
- First submitted
- 24 Oct 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema
- ClinicalTrials.gov ID
- NCT01715272
- Acronym / sponsor ID
- NER1008-01/2012 (DBC)
- Conditions
- Colonoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (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.
This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fleet enema | Active comparator | Drug: Fleet enemaThis group will receive Fleet enema as their treatment |
| TF037 | Experimental | Device: TF037This group will receive TF037 as their treatment |
Who may qualify
- Ages
- 18 to 60 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 (ECGs) at screening] aged 18 to 60 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 |
|---|---|---|
| TF037 | Device | TF037 |
| Fleet enema | Drug | Fleet enema |
Primary outcome
Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale
Time frame: Between 1 to 3 hours following enema administration
3 secondary outcomes
Stool output as measured by stool weight
Time frame: up to 1 hour following enema administration
Safety and tolerability as assessed by use of a Visual Analogue scale (VAS)
Time frame: 5 and 30 minutes following enema administration
Stool output over time
Time frame: 1 hour following enema administration
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 28 Feb 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.
Ronnie Beboso, MD principal investigator
BioKinetic Europe Ltd.
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 TF037 and Fleet enema in people with Colonoscopy, run by Norgine at 2 sites 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 28 Feb 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 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.
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?
Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale (time frame: Between 1 to 3 hours following enema administration). 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 28 Feb 2013.