Colon DiseasePhase 4PREP2TARGETNCT03428724
Individualized Bowel Preparation for Colonoscopy
A Phase 4 study testing Standard Preparation and Individualized Preparation in people with Colon Disease, run by Clinical Hospital Colentina at 2 sites in Romania.
Trial summary
A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Disease
- What is being tested?
- Standard Preparation and Individualized Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Feb 2018to 1 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective out-patient diagnostic or therapeutic colonoscopy
Who cannot join
- pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;
Trial locations and contacts
2 sites in 1 country.
Romania2 sites, 2 recruiting
- Recruiting
Colentina Clinical Hospital
Bucharest, 020125
Andreea Bengus, MD, 0040744497626, andreeabengus@yahoo.com
Theodor A Voiosu, MD
- Recruiting
Carol Davila Emergency Military Hospital
Bucharest
Vasile Balaban, MD, PhD, 00400742519793, vbalaban@yahoo.com
About this study
Official title: A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics
- Conditions
- Colon Disease
- Being tested
- Standard Preparation, Individualized Preparation
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PreparationDrug
standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)
Individualized PreparationDrug
individualized bowel preparation for colonoscopy (either split dose 4L PEG or split 2L PEG + ascorbic acid) based o patient characteristics (history of failed bowel preparation; use of laxative drugs, increased BMI, age>65, neurologic comorbidities)
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | standard polyethylene glycol preparation for colonoscopy Receives: Drug: Standard Preparation |
| individualized group | Experimental | either a low or a high volume bowel preparation according to patient characteristics Receives: Drug: Individualized Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel preparation quality
Boston bowel preparation score (BBPS)
Measured: 1-2 hours after completing bowel preparation
Secondary outcomes (1)
patient comfort during bowel preparation
0-10 patient comfort score using a standard visual-analogue scale
Measured: 1-2 hours after completing bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Feb 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
- Investigators
- Theodor Voiosu, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428724
- Sponsor's protocol ID
- COL-GASTRO-6
- Acronym
- PREP2TARGET
- Status last verified
- Jan 2019
- First submitted
- 5 Feb 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT03428724
- Acronym / sponsor ID
- PREP2TARGET / COL-GASTRO-6
- Conditions
- Colon Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 12 Feb 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.
A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Drug: Standard Preparationstandard polyethylene glycol preparation for colonoscopy |
| individualized group | Experimental | Drug: Individualized Preparationeither a low or a high volume bowel preparation according to patient characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective out-patient diagnostic or therapeutic colonoscopy
Key exclusion criteria (1 listed)
- pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;
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 |
|---|---|---|
| Standard Preparationstandard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid) | Drug | standard group |
| Individualized Preparationindividualized bowel preparation for colonoscopy (either split dose 4L PEG or split 2L PEG + ascorbic acid) based o patient characteristics (history of failed bowel preparation; use of laxative drugs, increased BMI, age>65, neurologic comorbidities) | Drug | individualized group |
Primary outcome
bowel preparation quality
Time frame: 1-2 hours after completing bowel preparation
Boston bowel preparation score (BBPS)
1 secondary outcome
patient comfort during bowel preparation
Time frame: 1-2 hours after completing bowel preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Related trials for Colon Disease
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
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.
Theodor Voiosu principal investigator
Clinical Hospital Colentina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Preparation and Individualized Preparation in people with Colon Disease, run by Clinical Hospital Colentina at 2 sites in Romania.
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 31 Jan 2019. 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 Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theodor Voiosu, MD, PhD (0726732764, theodor.voiosu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel preparation quality (time frame: 1-2 hours after completing bowel preparation). 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 31 Jan 2019.