Colonoscopy
Conditions
Keywords
Colon cleansing, Polyethylene Glycol, Sodium Phosphate
Brief summary
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
Detailed description
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
Interventions
DRUGMacrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
2L gut lavage solution
DRUGSodium Phosphate solution (NaP)
45 ml solution; BID
Sponsors
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm. | — |
| The taste of the solutions was assessed. | — |
| the overall judgment of the investigator for the colon preparation was documented. | — |
| All Adverse Events were recorded to evaluate the safety. | — |
| Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance. | — |
| Acceptability and tolerance for the subject was compared. | — |
Countries
Germany
Outcome results
None listed