ColonoscopyPhase 4NCT03698474
Comparison of Different Low Volume Solutions Prior to Colonoscopy
A Phase 4 study testing Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid and Natrium/ Kalium/ Magnesium sulfate in people with Colonoscopy, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
Trial summary
Study evaluates the head -to-head efficacy and tolerability of low volume preparations prior to colonoscopy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid and Natrium/ Kalium/ Magnesium sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Oct 2018to 12 Feb 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects referred to diagnostic or therapeutic colonoscopy
Who cannot join
- known or suspected bowel obstruction
- active bowel inflammation
- pregnancy
- prior bowel resection
- any presence of serious medical conditions ( cardiac, renal, liver disease)
- inability to obtain valid data from subject
- active bowel bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy
Study evaluates the head -to-head efficacy and tolerability of low volume preparations prior to colonoscopy
Read the detailed description
Aim of the study: To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate, polyethylene glycol/ascorbic acid and oral sulfate formula in a single or split dose regimen prior to colonoscopy
- Conditions
- Colonoscopy
- Being tested
- Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid, Natrium/ Kalium/ Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrium picosulfate / Magnesium citrateDrug
bowel preparation formula
Polyethylene glycol / Ascorbic acidDrug
bowel preparation formula
Natrium/ Kalium/ Magnesium sulfateDrug
bowel preparation formula
| Study group | Role | What they receive |
|---|---|---|
| SPMC-S | Active comparator | Natrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy Receives: Drug: Natrium picosulfate / Magnesium citrate |
| SPMC-D | Active comparator | Natrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy Receives: Drug: Natrium picosulfate / Magnesium citrate |
| PEGA-S | Active comparator | Polyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy Receives: Drug: Polyethylene glycol / Ascorbic acid |
| PEGA-D | Active comparator | Polyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy Receives: Drug: Polyethylene glycol / Ascorbic acid |
| SULF-S | Active comparator | Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy Receives: Drug: Natrium/ Kalium/ Magnesium sulfate |
| SULF-D | Active comparator | Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 0,5 L in the evening and 0,5L in the morning before colonoscopy Receives: Drug: Natrium/ Kalium/ Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory bowel preparation quality (Aronchick score 1-2)
Aronchick scale (1 -5)
Measured: one day
Secondary outcomes (1)
Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)
VAS scale 0-10 ( 0- the best, 10 - the worst)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start25 Oct 2018
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Responsible party
- Sponsor
- Investigators
- Vladimir Kojecky, Principal investigator, KNTB Zlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698474
- Sponsor's protocol ID
- BN102018
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy
- ClinicalTrials.gov ID
- NCT03698474
- Acronym / sponsor ID
- BN102018
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 9 Oct 2018 (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.
Study evaluates the head -to-head efficacy and tolerability of low volume preparations prior to colonoscopy
Detailed description
Aim of the study: To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate, polyethylene glycol/ascorbic acid and oral sulfate formula in a single or split dose regimen prior to colonoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SPMC-S | Active comparator | Drug: Natrium picosulfate / Magnesium citrateNatrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy |
| SPMC-D | Active comparator | Drug: Natrium picosulfate / Magnesium citrateNatrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy |
| PEGA-S | Active comparator | Drug: Polyethylene glycol / Ascorbic acidPolyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy |
| PEGA-D | Active comparator | Drug: Polyethylene glycol / Ascorbic acidPolyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy |
| SULF-S | Active comparator | Drug: Natrium/ Kalium/ Magnesium sulfateNatrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy |
| SULF-D | Active comparator | Drug: Natrium/ Kalium/ Magnesium sulfateNatrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 0,5 L in the evening and 0,5L in the morning before colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects referred to diagnostic or therapeutic colonoscopy
Key exclusion criteria (7 listed)
- known or suspected bowel obstruction
- active bowel inflammation
- pregnancy
- prior bowel resection
- any presence of serious medical conditions ( cardiac, renal, liver disease)
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 |
|---|---|---|
| Natrium picosulfate / Magnesium citratebowel preparation formula | Drug | SPMC-D, SPMC-S |
| Polyethylene glycol / Ascorbic acidbowel preparation formula | Drug | PEGA-D, PEGA-S |
| Natrium/ Kalium/ Magnesium sulfatebowel preparation formula | Drug | SULF-D, SULF-S |
Primary outcome
Satisfactory bowel preparation quality (Aronchick score 1-2)
Time frame: one day
Aronchick scale (1 -5)
1 secondary outcome
Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)
Time frame: one day
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 8 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Vladimir Kojecky principal investigator
KNTB Zlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid and Natrium/ Kalium/ Magnesium sulfate in people with Colonoscopy, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
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 7 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 8 Mar 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 Czechia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Satisfactory bowel preparation quality (Aronchick score 1-2) (time frame: one day). 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 8 Mar 2019.