A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution (NCT06597903) | Clinical Trial Compass
CompletedPhase 2
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
Germany36 participantsStarted 2001-05
Plain-language summary
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent must be obtained prior to inclusion
* Male or female
* Inpatients 18 to 60 years old with indication for complete colonoscopy
* Willing and able to complete the entire procedure and to comply with study instructions
* Females of childbearing potential must employ an adequate method of contraception.
Exclusion Criteria:
* Ileus
* Intestinal obstruction or perforation.
* Toxic megacolon.
* History of any colonic surgery.
* Cardiac Insufficiency (NYHA grad III and IV).
* Ischemic cardio vascular disease.
* Renal insufficiency (creatinine above 1.4 mg/100 ml).
* Cirrhosis of liver (child B or C).
* Known hypersensitivity to polyethylene glycols and/or Vitamin C.
* Concurrent participation in an investigational drug study or participation within 30 days of study entry.
* Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
* Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
* Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmgH).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.