Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00427089
First received: January 25, 2007
Last updated: April 15, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
Drug: Sodium Phosphate solution (NaP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").

Secondary Outcome Measures:
  • the "overall" judgment of the investigator for the colon preparation was documented.
  • Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
  • The taste of the solutions was assessed.
  • Acceptability and tolerance for the subject was compared.
  • All Adverse Events were recorded to evaluate the safety.
  • Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.

Enrollment: 360
Study Start Date: September 2004
Estimated Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: 1
2L gut cleansing solution
Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
2L gut lavage solution
Other Name: MOVIPREP®
Active Comparator: 2 Drug: Sodium Phosphate solution (NaP)
45 ml solution; BID

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 Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject's written informed consent had to be obtained prior to inclusion.
  2. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
  3. Willing, able and competent to complete the entire procedure and to comply with study instructions
  4. Females of childbearing potential had to employ an adequate method of contraception

Exclusion Criteria:

  1. Ileus
  2. Intestinal obstruction or perforation
  3. Toxic megacolon
  4. History of colonic resection
  5. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
  6. Congestive heart failure (NYHA III + IV)
  7. Acute life threatening cardiovascular disease
  8. Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
  9. Known moderate to severe renal insufficiency
  10. Severe renal failure
  11. Severe liver failure
  12. Known glucose 6 phosphatase dehydrogenase deficiency
  13. Known phenylketonuria
  14. Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
  15. Concurrent participation in an investigational drug study or participation within 30 days of study entry
  16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
  17. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427089

Locations
Germany
Klinikum Aschaffenburg Am Hasenkopf 1
Aschaffenburg, Bayern, Germany, 63739
Schiessgrabenstr. 34
Augsburg, Bayern, Germany, 86150
Spardorfer Str. 39
Erlangen, Bayern, Germany, 91054
Heiligengrabstr. 22
Hof, Bayern, Germany, 95028
Rätestr. 20
Kirchheim, Bayern, Germany, 85551
Sternbergstr. 8
Regensburg, Bayern, Germany, 93047
Dieburger Str. 29
Darmstadt, Hessen, Germany, 64287
Unter den Eichen 26
Oldenburg, Niedersachsen, Germany, 26122
Erzbergstr. 113
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
Erfurt, Thüringen, Germany, 99097
Uferstr. 3
Minden, Westfalen-Lippe, Germany, 32423
Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
Hamburg, Germany, 22297
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Christian Ell, Prof Dr med Dr. Horst Schmidt Kliniken GmbH
  More Information

Publications:
Ell C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18

Responsible Party: Hans-Jürgen Gruss, Norgine
ClinicalTrials.gov Identifier: NCT00427089     History of Changes
Other Study ID Numbers: NRL 994-01/2004 (HSG)
Study First Received: January 25, 2007
Last Updated: April 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Norgine:
Colon cleansing
Polyethylene Glycol
Sodium Phosphate

Additional relevant MeSH terms:
Ascorbic Acid
Pharmaceutical Solutions
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014