Clinical Evaluation of a New Reduced Volume Bowel Preparation

Study Overview
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Brief Summary
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Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Detailed Description
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Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new Low Dose Bowel Prep formulation for gut cleansing prior to colonoscopy. Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the Low Dose Bowel Prep using a one-step intake mode.

Official Title
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A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution (Low Dose Bowel Prep) in 30 Patients Submitted to Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, inpatients 18 to 65 years old with indication for complete colonoscopy the patient's written informed consent must be obtained prior to inclusion willing and able to complete the entire procedure and to comply with study instructions Exclusion Criteria: ileus or toxic megacolon intestinal obstruction or perforation known of G6PD insufficiency history of any colonic surgery ischaemic cardiovascular disease untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg) renal insufficiency (creating above 45µmol/l) abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit cirrhosis of liver (Child-Pugh grade B or C) females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception. concurrent participation in an investigational drug study or participation within 30 days of study entry 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured by a final scoring system i.e., the overall quality of colonoscopy prep that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0). |  |  | 
| Amount of fluid removed from the colon during the colonoscopy. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon cleansing