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CompletedNCT00321230Updated Apr 16, 2008

Clinical Evaluation of a New Reduced Volume Bowel Preparation

A Phase 2 interventional study of macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate in Colonoscopy, sponsored by Norgine. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-16.

Sponsored by Norgine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Read the detailed 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.

02

Conditions studied

  • Colonoscopy

Keywords

  • Colon cleansing
03

In context

Lead sponsor

Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • Drugmacrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
06

What researchers measure

Primary outcomes

  1. Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.

Secondary outcomes

  1. Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).

  2. Amount of fluid removed from the colon during the colonoscopy.

07

Study locations

1 site
  • Hôpital Lariboisière, Endoscopy Department
    Paris, 75010, France
08

References and documents

Publications

  • Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5. PubMed 7380204 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00321230
Lead sponsor
Norgine
First posted
May 3, 2006
Start date
Jan 2001
Completion
May 2001
Last update
Apr 16, 2008

Study contacts

Alain Bitoun, MD
principal investigator · Hôpital Lariboisière

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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