Clinical trial NCT00321230: Clinical Evaluation of a New Reduced Volume Bowel Preparation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Keywords: Colon cleansing
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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).
measure: Amount of fluid removed from the colon during the colonoscopy.
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière, Endoscopy Department
Study officials:
affiliation: Hôpital Lariboisière
name: Alain Bitoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.