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Compares treatment options for Elective Colonoscopy
Official title Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
ClinicalTrials.gov ID: NCT07465705
What this study is testing
What is 100g of Mannitol?
100g of Mannitol is an investigational medicine, being studied as a potential treatment for elective colonoscopy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability of subject to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- people willing and able to complete the entire study and to comply with instructions.
You likely can't join if
- Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods...
- Severe acute and chronically active inflammatory bowel disease; people in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn...
- Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
- Severe heart failure: New York Heart Association (NYHA) Class III-IV.
- Severe anaemia (Hb ≤ 8 g/dl).
- Chronic liver disease Child-Pugh class B or C.
See the full eligibility criteria
- Ability of subject to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- people willing and able to complete the entire study and to comply with instructions.
- Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG...
- Severe acute and chronically active inflammatory bowel disease; people in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative...
- Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
- Severe heart failure: New York Heart Association (NYHA) Class III-IV.
- Severe anaemia (Hb ≤ 8 g/dl).
- Chronic liver disease Child-Pugh class B or C.
- Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
- Clinically significant alterations of baseline haemato-chemical parameters.
- Recent (\< 6 months) symptomatic acute ischemic heart disease.
- History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving...
- History of paralysis of the gut (ileus).
- History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- History of phenylketonuria (due to presence of aspartame).
- History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- History of toxic megacolon.
- Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.
- Suspected bowel obstruction or perforation.
- Indication for partial colonoscopy.
- people who received an investigational drug or therapy within 5 half-lives of the first visit.
- Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- Underwater colonoscopy instead of standard gas insufflation.
The study team makes the final eligibility decision.
Where it's taking place
- Anderlecht, Belgium
- Leuven, Belgium
- Ostend, Belgium
- Carpi, Modena, Italy
- Aviano, Pordenone, Italy
- Negrar, Verona, Italy
- Bologna, Italy
- Brescia, Italy
- Como, Italy
- Milan, Italy
- Roma, Italy
- Trento, Italy
- Tychy, Poland
- Warsaw, Poland
- Barcelona, Spain
- Örebro, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anderlecht, Belgium; Leuven, Belgium; Ostend, Belgium; Carpi, Modena, Italy; Aviano, Pordenone, Italy; Negrar, Verona, Italy and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.