Clinical Evaluation of a New Reduced Volume Bowel Preparation
Phase 2
Completed
- Conditions
- Colonoscopy
- Registration Number
- NCT00321230
- Lead Sponsor
- Norgine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Hôpital Lariboisière, Endoscopy Department
🇫🇷Paris, France
Hôpital Lariboisière, Endoscopy Department🇫🇷Paris, France