NCT00321230

Brief Summary

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

First QC Date

May 2, 2006

Last Update Submit

April 15, 2008

Conditions

Colonoscopy

Keywords

Colon cleansing

Outcome Measures

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 (2)

  • 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).

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

Interventions

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
  • willing and able to complete the entire procedure and to comply with study instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière, Endoscopy Department

Paris, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 7380204BACKGROUND

Study Officials

  • Alain Bitoun, MD

    Hôpital Lariboisière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

January 1, 2001

Study Completion

May 1, 2001

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

FR(1)