Clinical Evaluation of a New Reduced Volume Bowel Preparation

Norgine

Status and phase

Completed

Phase 2

Conditions

Colonoscopy

Treatments

Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00321230

02/2000

NRL994-02/2000

Details and patient eligibility

About

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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