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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
* Drug: Sodium Phosphate solution (NaP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject's written informed consent had to be obtained prior to inclusion. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening Willing, able and competent to complete the entire procedure and to comply with study instructions Females of childbearing potential had to employ an adequate method of contraception Exclusion Criteria: Ileus Intestinal obstruction or perforation Toxic megacolon History of colonic resection Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs) Congestive heart failure (NYHA III + IV) Acute life threatening cardiovascular disease Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg) Known moderate to severe renal insufficiency Severe renal failure Severe liver failure Known glucose 6 phosphatase dehydrogenase deficiency Known phenylketonuria Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C Concurrent participation in an investigational drug study or participation within 30 days of study entry Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2L gut cleansing solution | Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate<br>* 2L gut lavage solution<br>* Other names: MOVIPREP®;|
| Active Comparator: 2<br> | Drug: Sodium Phosphate solution (NaP)<br>* 45 ml solution; BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall judgment of the investigator for the colon preparation was documented. |  |  | 
| 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. |  |  | 
| Acceptability and tolerance for the subject was compared. |  |  | 
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon cleansing, Polyethylene Glycol, Sodium Phosphate