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Evaluation of the effectiveness and tolerance of the macrogol 3350 and electrolytes combination, as a second-line intestinal preparation regimen for colonoscopy with sodium picosulfate/magnesium citrate: a randomized, placebo-controlled, study (PICO-TRAT STUDY)
EU CTIS ID: 2025-520818-65-00
What this study is testing
The aim of the study is to evaluate the efficacy of the combination of CLINITRAT and PICOPREP medicinal products in bowel preparation before colonoscopy in patients with inadequate preparation at reference 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
- Women and/or men at least 18 years old
- Women and/or men with inadequate preparation on reference colonoscopy, score <6 points according to the Boston Bowel Preparation Scale (BBPS)
- Patients who are legally competent and capable of understanding the information provided about the study, have been informed about the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
You likely can't join if
- Common contraindications for colonoscopy (suspected perforation, toxic megacolon, pyloric stenosis, severe colitis, pregnancy, lactation)
- Type I diabetes
- Patients with colon segmental resection
- Patients suffering from severe dehydration
- Rhabdomyolysis
- Hypermagnesemia
See the full eligibility criteria
- Women and/or men at least 18 years old
- Women and/or men with inadequate preparation on reference colonoscopy, score <6 points according to the Boston Bowel Preparation Scale (BBPS)
- Patients who are legally competent and capable of understanding the information provided about the study, have been informed about the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
- Common contraindications for colonoscopy (suspected perforation, toxic megacolon, pyloric stenosis, severe colitis, pregnancy, lactation)
- Type I diabetes
- Patients with colon segmental resection
- Patients suffering from severe dehydration
- Rhabdomyolysis
- Hypermagnesemia
- Patients suffering from active inflammatory bowel disease
- Intestinal obstruction or perforation
- Ileus, gastric retention, acute intestinal or gastric ulceration
- Acute abdominal conditions requiring immediate surgery, such as acute appendicitis
- Nausea and vomiting
- Allergy or hypersensitivity to study drugs
- Toxic megacolon
- Non-compliance with instructions for bowel preparation during reference colonoscopy (receiving <75% of bowel preparation)
- Polyposis syndrome and refusal to participate in the study
- Pregnancy
- Lactation
- Participation in another study of an investigational medicinal product or investigational medical device
- Severe heart failure (NYHA III/IV)
- Severe chronic kidney disease (eGFR<30)
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.