Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

Norgine

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Drug: Sodium Phosphate solution (NaP); Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427089

NRL 994-01/2004 (HSG)

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

1

Experimental group

Description:

2L gut cleansing solution

Treatment:

Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

2

Active Comparator group

Treatment:

Drug: Sodium Phosphate solution (NaP)