Colonoscopy
Conditions
Keywords
Colon cleansing
Brief summary
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
Detailed description
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.
Interventions
Sponsors
Norgine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. | — |
Countries
France
Outcome results
None listed