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Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy (LOWOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297423
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Casen Recordati S.L.
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
María Pellisé, Hospital Clinic of Barcelona

Brief 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 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Plenvu Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A comparative, parallel, randomized, non-inferiority, non-blinded, single-centre and low-intervention clinical trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado
Estimated Study Start Date : March 17, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Plenvu
Plenvu split dose
Drug: Plenvu
randomization 1:1
Other Name: citrafleet

Active Comparator: Citrafleet
citrafleet in split dose
Drug: Plenvu
randomization 1:1
Other Name: citrafleet




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 1 year ]
    The percentage of patients with at least one adenoma in relation to the total subjects in each group of study


Secondary Outcome Measures :
  1. Colonoscopy quality [ Time Frame: 1 year ]
    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.

  2. Lesion detection rate [ Time Frame: 1 year ]
    The percentage of patients with at least one polyp in relation to the total subjects in each group

  3. Caecal intubation rate [ Time Frame: 1 year ]
    If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete

  4. Rate of adverse events related to the administration of the preparation [ Time Frame: 1 year ]
    Evaluated with the Tolerability and Satisfaction Questionnaire including symptoms such as nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, and dry mouth

  5. Tolerability and satisfaction with preparation [ Time Frame: 1 year ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297423


Contacts
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Contact: María Pellisé, MD PhD +34 932275400 ext 2675 mpellise@clinic.cat

Sponsors and Collaborators
Hospital Clinic of Barcelona
Casen Recordati S.L.
Fundacion Clinic per a la Recerca Biomédica
Additional Information:
Publications:

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Responsible Party: María Pellisé, Principal Investigator. Attending physician Gastroenterology department., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04297423    
Other Study ID Numbers: HCB/2019/0872
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Pellisé, Hospital Clinic of Barcelona:
Bowel Preparation Solutions
Screening colonoscopy
Adenoma detection rate
Tolerability
1L PEG plus ascorbate
Magnesium citrate plus picosulphate
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases