BridgeMD
A phase III, international, multiCenter, randomized, paraLlel-group, Endoscopist-blinded non-inferiority study of the efficAcy, safety and patient acceptance of mannitol veRsus Plenvu® in boWel prepAration for elective colonoscopY. CLEARWAY
EU CTIS ID: 2025-521451-23-00
What this study is testing
To demonstrate the non-inferiority of mannitol vs. standard Plenvu® same-day dosing regimen in bowel cleansing for colonoscopy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability of patient to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- Patients 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 of birth control throughout the study period, according to the CTCG “Recommendations related to contraception and pregnancy testing in clinical trials” v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
- Recent (< 6 months) symptomatic acute ischemic heart disease.
- History of paralysis of the gut (ileus).
- History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- 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 the structure and function of the colon.
See the full eligibility criteria
- Ability of patient to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- Patients 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 “Recommendations related to contraception and pregnancy testing in clinical trials” v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
- Recent (< 6 months) symptomatic acute ischemic heart disease.
- History of paralysis of the gut (ileus).
- History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- 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 the structure and function of the colon.
- 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.
- Patients 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.
- Severe acute and chronically active inflammatory bowel disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.
- Underwater colonoscopy instead of standard gas insufflation.
- History of toxic megacolon.
- History of phenylketonuria (due to presence of aspartame).
- 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.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.