Clinical trial · Interventional
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
NCT06597903CI-TRIAL-00080507completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NRL994 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NRL994 low dose bowel prep (LDBP)
- description
- Patients given two doses of NRL994, one on the evening before and one on the morning of their scheduled colonoscopy. Degree of gut cleansing was rated by the colonoscopist and an independent reviewer. Volume of fluid aspirated during colonoscopy and weight of stools/volume of urine from start of cleansing to start of colonoscopy were also measured. Number of patients who reached clear effluent evaluated.
- interventionNames
- Drug: NRL994
Primary outcomes (8)
- measure
- Degree of gut cleansing
- timeFrame
- Day 0 during colonoscopy
- description
- Degree of gut cleansing in each of five predefined gut segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon) rated on a 5-level verbal rating scale (VRS) ranging from 4 (very good) to 0 (very bad) by 1. the physician performing the endoscopic procedure and 2. by an independent reviewer on the basis of video tapes registered during colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.