Status:
COMPLETED
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
Lead Sponsor:
Norgine
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) w...
Detailed Description
A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy. The study was carried out as an open, ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained prior to inclusion
- Male or female
- Inpatients 18 to 60 years old with indication for complete colonoscopy
- Willing and able to complete the entire procedure and to comply with study instructions
- Females of childbearing potential must employ an adequate method of contraception.
Exclusion
- Ileus
- Intestinal obstruction or perforation.
- Toxic megacolon.
- History of any colonic surgery.
- Cardiac Insufficiency (NYHA grad III and IV).
- Ischemic cardio vascular disease.
- Renal insufficiency (creatinine above 1.4 mg/100 ml).
- Cirrhosis of liver (child B or C).
- Known hypersensitivity to polyethylene glycols and/or Vitamin C.
- Concurrent participation in an investigational drug study or participation within 30 days of study entry.
- Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
- 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.
- Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
- Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmgH).
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2002
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06597903
Start Date
May 1 2001
End Date
March 1 2002
Last Update
September 19 2024
Active Locations (1)
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1
Med. Klinik der
Wuppertal, Germany, D-42107