Clinical trial · Interventional
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.
NCT00427089CI-TRIAL-00001406completedPhase 3ClinicalTrials.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)
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
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 |
|---|---|---|---|
| Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate | Drug | — | UNRESOLVED |
| Sodium Phosphate solution (NaP) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 2L gut cleansing solution
- interventionNames
- Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: Sodium Phosphate solution (NaP)
Primary outcomes (1)
- measure
- Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject's written informed consent had to be obtained prior to inclusion. 2. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening 3. Willing, able and competent to complete the entire procedure and to comply with study instructions 4. Females of childbearing potential had to employ an adequate method of contraception Exclusion Criteria: 1. Ileus 2. Intestinal obstruction or perforation 3. Toxic megacolon 4. History of colonic resection 5. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs) 6. Congestive heart failure (NYHA III + IV) 7. Acute life threatening cardiovascular disease 8. Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmHg) 9. Known moderate to severe renal insufficiency 10. Severe renal failure 11. Severe liver failure 12. Known glucose 6 phosphatase dehydrogenase deficiency 13. Known phenylketonuria 14. Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C 15. Concurrent participation in an investigational drug study or participation within 30 days of study entry 16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception 17. Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.
References
Publications (2)
- RESULTEll C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18
- DERIVEDEll C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23. PMID 25180609