Clinical Evaluation of a New Reduced Volume Bowel Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2001-05-31

Brief Summary

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Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Detailed Description

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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.

Conditions

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Colonoscopy

Keywords

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Colon cleansing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Norgine

Principal Investigators

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Alain Bitoun, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Lariboisière

Locations

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Hôpital Lariboisière, Endoscopy Department

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

PMID: 7380204 (View on PubMed)

Other Identifiers

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02/2000

Identifier Type: -

Identifier Source: secondary_id

NRL994-02/2000