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OpenTrials
Completed

NCT Number: NCT00321230

Clinical Evaluation of a New Reduced Volume Bowel Preparation

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

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Key information

Conditions

Colonoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Lariboisière, Endoscopy Department

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate

Drug

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.

Sponsors and collaborators

Lead sponsor

Norgine

Industry

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2001
First posted
May 3, 2006
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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