Status:
COMPLETED
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
Lead Sponsor:
Norgine
Conditions:
Colonoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
Detailed Description
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Mov...
Eligibility Criteria
Inclusion
- The subject's written informed consent had to be obtained prior to inclusion.
- Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
- Willing, able and competent to complete the entire procedure and to comply with study instructions
- Females of childbearing potential had to employ an adequate method of contraception
Exclusion
- Ileus
- Intestinal obstruction or perforation
- Toxic megacolon
- History of colonic resection
- Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
- Congestive heart failure (NYHA III + IV)
- Acute life threatening cardiovascular disease
- Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmHg)
- Known moderate to severe renal insufficiency
- Severe renal failure
- Severe liver failure
- Known glucose 6 phosphatase dehydrogenase deficiency
- Known phenylketonuria
- Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
- Concurrent participation in an investigational drug study or participation within 30 days of study entry
- Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
- Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00427089
Start Date
September 1 2004
End Date
May 1 2005
Last Update
April 16 2008
Active Locations (12)
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1
Klinikum Aschaffenburg Am Hasenkopf 1
Aschaffenburg, Bavaria, Germany, 63739
2
Schiessgrabenstr. 34
Augsburg, Bavaria, Germany, 86150
3
Spardorfer Str. 39
Erlangen, Bavaria, Germany, 91054
4
Heiligengrabstr. 22
Hof, Bavaria, Germany, 95028