Status:
COMPLETED
A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution
Lead Sponsor:
Norgine
Conditions:
Colonoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The study was carried out as a randomised, single-blind, active-controlled, multi-centric, phase III study with two parallel treatment groups. The primary efficacy criterion was the frequency of effec...
Detailed Description
The study was designed as a randomised, active-controlled, single-blind, multi-centre, pivotal phase III trial with two parallel treatment groups. 15 German hospitals with specialised gastroenterology...
Eligibility Criteria
Inclusion
- written informed consent prior to inclusion;
- male or female in-patients, aged 18 to 85 years, with indication for complete colonoscopy;
- willing and able to complete the entire procedure and to comply with study instructions;
- females of childbearing potential employing an adequate method of contraception.
Exclusion
- ileus;
- intestinal obstruction or perforation;
- toxic megacolon;
- congestive heart failure (NYHA class III and IV);
- acute life-threatening cardiovascular disease;
- untreated or uncontrolled arterial hypertension (SBP max\>170mmHg, DBP min\>100mmHg);
- severe renal failure;
- severe liver failure;
- known glucose-6-phosphatase dehydrogenase deficiency;
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00389233
Start Date
June 1 2002
End Date
December 1 2002
Last Update
April 16 2008
Active Locations (12)
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1
Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien
Amberg, Germany, 92224
2
Chefarzt Innere Medizin, Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
3
Klinikum Dachau, Innere Medizin - Gastroenterologie
Dachau, Germany
4
Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk
Erfurt, Germany, 99097