BridgeMD
Compares treatment options for Bowel Cleansing Prior to Clinical Procedures
Official title A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
ClinicalTrials.gov ID: NCT07218523
What this study is testing
What is PLENVU®?
PLENVU® is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bowel cleansing prior to clinical procedures.
Also referred to as NER1006.
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
- The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Colonoscopy is a crucial procedure that helps to diagnose and manage various gastrointestinal (GI) conditions in paediatric patients.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- Participants who require a colonoscopy.
- Must weigh a minimum of 10 kg, and participants aged 1 to \< 4 years of age must be above the 10th percentile of weight for age.
- Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative [e.g. three ambiguous results]) within...
- Must use a highly effective method of contraception (failure rate \< 1% per year) from Day 1 and throughout the Safety Follow-up Period.
- Must not be breastfeeding.
You likely can't join if
- Has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical...
- Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries.
- Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
- Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g...
See the full eligibility criteria
- Participants who require a colonoscopy.
- Must weigh a minimum of 10 kg, and participants aged 1 to \< 4 years of age must be above the 10th percentile of weight for age.
- Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative [e.g. three ambiguous results]) within 24 hours before the first dose of study intervention.
- Must use a highly effective method of contraception (failure rate \< 1% per year) from Day 1 and throughout the Safety Follow-up Period.
- Must not be breastfeeding.
- Participant is able to receive regular external feeding without breastfeeding.
- Has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution).
- Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries.
- Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
- Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
- Has a history of uncontrolled hypertension.
- Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and/or has used one or more laxatives within 72 hours prior to administration of the...
- Has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
- Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
- Has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures) or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants) or has used seizure...
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerp, Belgium
- Jette, Brussels Capital, Belgium
- Alleur, Liege, Belgium
- Regensburg, Bavaria, Germany
- Münster, North Rhine-Westphalia, Germany
- Wuppertal, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Berlin, State of Berlin, Germany
- Budapest, Budapest, Hungary
- Miskolc, Miskolc, Hungary
- Bergamo, Bergamo, Italy
- Florence, Firenze, Italy
- Messina, Messina, Italy
- Milan, Milano, Italy
- Naples, Napoli, Italy
- Roma, Roma, Italy
- Breda, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Zwolle, Overijssel, Netherlands
- Torun, Kuyavian-Pomeranian Voivodeship, Poland
+ 16 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Antwerp, Belgium; Jette, Brussels Capital, Belgium; Alleur, Liege, Belgium; Regensburg, Bavaria, Germany; Münster, North Rhine-Westphalia, Germany; Wuppertal, North Rhine-Westphalia, Germany and 30 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.