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Colorectal CancerPhase 4LOWOLNCT04297423

Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy

A Phase 4 study testing Plenvu in people with Colorectal Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are performed annually at Hospital Clínic de… Read more about this study

Who is it for?
Ages 50 to 69 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Plenvu
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,002 participants
Where
1 siteSpain
Study dates
11 Mar 2020to 28 Jun 2022
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 50 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 50 to 69 years who have participated in the early detection programme for colon and rectal cancer (PDPCCR) in Barcelona, who have obtained a positive result in the faecal occult blood test (≥20 μg Hb/g faeces) and who are scheduled for a screening colonoscopy at Hospital Clínic de Barcelona.

Who cannot join

  • People who do not agree to participate in the study.
  • People with known severe renal failure (grade IV or V) and grade III and IV heart failure according to the New York Heart Association (NYHA) Scale of Functional Assessment of Heart Failure
  • Individuals who have undergone a colonoscopy in the past year.
  • Subjects meeting the Rome IV Criteria for the diagnosis of functional constipation
  • Subjects with mental disabilities or with a severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders).
  • Individuals who do not understand Catalan or Spanish verbally and in writing.
Show all 17Show fewer
  • Individuals with partial or total colon resection.
  • Individuals with a personal history of CRC or colorectal disease amenable to specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
  • Individuals with terminal illness or severe illness/disability that contraindicates further study of the colon.
  • People with gastrointestinal disorders that contraindicate the use of the study products (gastric emptying disorders, perforation or gastrointestinal obstruction, ileus, toxic megacolon).
  • People with congestive heart failure
  • Hypermagnesemia
  • Rhabdomyolysis
  • Phenylketourine
  • Glucose-6-phosphate dehydrogenase deficiency
  • People with hypersensitivity to the active ingredients of excipients
  • People with severe renal impairment

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital CLinic

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

Official title: Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado

Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are performed annually at Hospital Clínic de Barcelona. Adequate colon preparation (anterograde cleansing with laxatives) improves polyp detection, decreases examination time, and complications. There are both low and high volume intestinal regimens with polyethylene glycol (PEG) as the main active ingredient or without it.

Hypothesis: Two low volumen regimens, 1L PEG plus ascorbate and magnesium citrate plus picosulphate, at starting doses have the same Adenoma Detection Rate as cleansing solutions in preparation for screening colonoscopy.

Read the detailed description

The primary objective of the study is to compare the clinical efficacy (by comparing the adenoma detection rate) of 1L PEG plus ascorbate versus magnesium citrate plus picosulphate in subjects undergoing colonoscopy in a colorectal cancer screening programme. We also will compare the Lesion Detection Rate, the quality of colon cleansing (Boston classification) overall and by segments, the tolerability and satisfaction and the rate of adverse effects experienced with intake of these products.

Methodology: A comparative, parallel, randomized, single-centre, low-intervention clinical trial to be conducted at the CCR screening unit of Hospital Clínic de Barcelona that will include 1,002 participants.

Subjects will complete a Tolerability and Satisfaction Questionnaire after completing the bowel preparation. Findings (polyps, CRC, or other lesions) and quality of bowel cleansing will be collected from the colonoscopy report.

Being tested
Plenvu
Keywords
Bowel Preparation Solutions, Screening colonoscopy, Adenoma detection rate, Tolerability, 1L PEG plus ascorbate, Magnesium citrate plus picosulphate
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlenvuDrug

    Also called citrafleet

    randomization 1:1

Study groups in NCT04297423
Study groupRoleWhat they receive
PlenvuExperimentalPlenvu split dose
Receives: Drug: Plenvu
CitrafleetActive comparatorcitrafleet in split dose
Receives: Drug: Plenvu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma detection rate

    The percentage of patients with at least one adenoma in relation to the total subjects in each group of study

    Measured: 2 years

Secondary outcomes (5)

  1. Colonoscopy quality

    Colonoscopy quality is assess with Boston Bowel Preparation Scale (BBPS) in which each colon segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). It will be considered adequate when each segment is scored ≥2.

    Measured: 2 years

  2. Lesion detection rate

    The percentage of patients with at least one polyp in relation to the total subjects in each group

    Measured: 2 years

  3. Caecal intubation rate

    If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete

    Measured: 2 years

  4. Rate of adverse events related to the administration of the preparation

    Evaluated with the Tolerability and Satisfaction Questionnaire including symptoms such as nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, and dry mouth

    Measured: 2 years

  5. Tolerability and satisfaction with preparation

    Assessed by completing a tolerability and satisfaction questionnaire that has been prepared from the validated questionnaire Mayo Clinic Bowel Prep Tolerability Questionnaire (Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep; 46(9):808-12.doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19. PubMed PMID: 24953203) and which has been adapted and translated into Spanish

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start11 Mar 2020
  3. Primary completion28 Jun 2022
  4. Study completion28 Jun 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A comparative, parallel, randomized, non-inferiority, non-blinded, single-centre and low-intervention clinical trial
Masking
None (open label)
Enrolment
1,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297423
Sponsor's protocol ID
HCB/2019/0872
Acronym
LOWOL
Status last verified
Sep 2022
First submitted
4 Mar 2020
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.

    PubMed 24918005

  • Schreiber S, Baumgart DC, Drenth JPH, Filip RS, Clayton LB, Hylands K, Repici A, Hassan C; DAYB Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):73-84. doi: 10.1055/a-0639-5070. Epub 2018 Jul 19.

    PubMed 30025415

  • Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M; MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):60-72. doi: 10.1055/a-0638-8125. Epub 2018 Jul 19.

    PubMed 30025414

  • DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.

    PubMed 28803744

  • Seo SI, Kang JG, Kim HS, Jang MK, Kim HY, Shin WG. Efficacy and tolerability of 2-L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate: a randomized controlled trial. Int J Colorectal Dis. 2018 May;33(5):541-548. doi: 10.1007/s00384-018-2989-7. Epub 2018 Mar 1.

    PubMed 29497812

  • Lee SW, Bang CS, Park TY, Suk KT, Baik GH, Kim DJ. Split-dose Bowel Preparation for Colonoscopy: 2 Liters Polyethylene Glycol with Ascorbic Acid versus Sodium Picosulfate versus Oral Sodium Phosphate Tablets. Korean J Gastroenterol. 2017 Aug 25;70(2):89-95. doi: 10.4166/kjg.2017.70.2.89.

    PubMed 28830134

  • Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

    PubMed 19136102

  • Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep;46(9):808-12. doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19.

    PubMed 24953203

  • Guillaumes S, O'Callaghan CA. [Spanish adaptation of the free OxMaR software for minimization and randomization of clinical studies]. Gac Sanit. 2019 Jul-Aug;33(4):395-397. doi: 10.1016/j.gaceta.2018.07.013. Epub 2018 Nov 1. Spanish.

    PubMed 30390995

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Plenvu in people with Colorectal Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 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 9 Sep 2022. 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 Spain. 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?

Adenoma detection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297423, which also lists 9 linked publications.

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 9 Sep 2022.

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