Clinical Evaluation of a New Reduced Volume Bowel Preparation

Colonoscopy Clinical Trial

Official title:

A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321230
• Other study ID #: NRL994-02/2000
• Secondary ID: 02/2000
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2006
• Last updated: April 15, 2008
• Start date: January 2001
• Est. completion date: May 2001

Study information

• Verified date: April 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Locations

Country	Name	City	State
France	Hôpital Lariboisière, Endoscopy Department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	Amount of fluid removed from the colon during the colonoscopy.