Pharmacological ActionPhase 1NCT03904303
Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep
A Phase 1 study testing A 06 ad in people with Pharmacological Action, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- A 06 ad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2019to 31 Dec 2020
- 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
Who cannot join
- Allergy to content of products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
Read the detailed description
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.
Study performed in health subjects.
- Conditions
- Pharmacological Action
- Being tested
- A 06 ad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 06 adDrug
Colonic cleansing before colonoscopy and CT colonografi
| Study group | Role | What they receive |
|---|---|---|
| Geloprep | Experimental | Novel and patented Polyethylene glycol 3350 mixture Receives: Drug: A 06 ad |
| Moviprep | Active comparator | Standard of care Polyethylene glycol 3350 mixture Receives: Drug: A 06 ad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel preparation scale (BBPscale)
Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9.
Measured: Performed during the endoscopy procedure
Adverse events related to intervention
Any adverse event related to the intervention observed by investigators or as reported by the participant
Measured: Assessed 4 hours after last intake of cleansing product
Secondary outcomes (4)
Blood pressure
mmHg systolic and diastolic measured on right or left arm.
Measured: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Saturation
Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%.
Measured: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Heart rate
Heart rate
Measured: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Respiration frequency
Respiration frequency
Measured: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Ismail Gögenur, Professor MD, Study chair, Department of Surgery, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904303
- Sponsor's protocol ID
- REG-014-2018
- Status last verified
- Jun 2019
- First submitted
- 29 Jan 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study
- ClinicalTrials.gov ID
- NCT03904303
- Acronym / sponsor ID
- REG-014-2018
- Conditions
- Pharmacological Action
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Apr 2019 (actual)
- 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.
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
Detailed description
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.
Study performed in health subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geloprep | Experimental | Drug: A 06 adNovel and patented Polyethylene glycol 3350 mixture |
| Moviprep | Active comparator | Drug: A 06 adStandard of care Polyethylene glycol 3350 mixture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Allergy to content of products
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 |
|---|---|---|
| A 06 adColonic cleansing before colonoscopy and CT colonografi | Drug | Geloprep, Moviprep |
Primary outcome
Boston Bowel preparation scale (BBPscale)
Time frame: Performed during the endoscopy procedure
Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9.
Adverse events related to intervention
Time frame: Assessed 4 hours after last intake of cleansing product
Any adverse event related to the intervention observed by investigators or as reported by the participant
4 secondary outcomes
Blood pressure
Time frame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Saturation
Time frame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Heart rate
Time frame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Respiration frequency
Time frame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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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.
Ismail Gögenur, Professor MD study chair
Department of Surgery, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A 06 ad in people with Pharmacological Action, run by Zealand University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2019. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne Holm, RN (+4593567014, hanh@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel preparation scale (BBPscale) (time frame: Performed during the endoscopy procedure). The study lists 2 primary outcomes in all. 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 6 Jun 2019.