MOVIPREP® Versus PICOLAX® Pilot Study

December 12, 2007 updated by: Norgine

A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®)

This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy.

The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy.

The secondary objectives are to evaluate the safety, tolerability and acceptability of MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x sachet B) in the morning of the colonoscopy, or PICOLAX®, 150 mL solution (1 sachet) before 8am on day prior to the day of colonoscopy, and 150 mL solution (1 sachet) 6 to 8 hours later.

The primary efficacy measure will be the degree of gut cleansing, as assessed by the physician performing the colonoscopy. A 5-grade scale will be used to assess each of the predefined colon areas, resulting in a final grading (A to D) of the overall quality of the bowel preparation treatment. Grades A and B will be considered as success, and Grades C and D as failure.

The secondary efficacy measures will be:

  • is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
  • taste acceptability
  • ease of taking, and ability to complete the bowel preparation treatment
  • recommended diet compliance
  • would the patient be prepared to repeat the bowel preparation treatment if necessary?
  • well-being and effect on usual activities whilst taking the bowel preparation treatment
  • overall impression of the bowel preparation treatment prior to colonoscopy
  • symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy

Safety and tolerability will be assessed through the collection of adverse events, clinical laboratory tests, physical examination, weight and vital signs (blood pressure and pulse rate) data.

Number of patients:

It is intended to recruit approximately 70 patients in order to achieve at least 60 evaluable patients using a randomisation ratio of 1:1 MOVIPREP®: PICOLAX®.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent obtained prior to inclusion
  • male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete colonoscopy
  • willing, able and competent to complete the entire procedure and to comply with study instructions
  • females of childbearing potential must employ an adequate method of contraception
  • if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy
  • females of childbearing potential must undergo a pregnancy test

Exclusion Criteria:

  • ileus
  • gastro-intestinal obstruction or perforation
  • toxic megacolon, toxic colitis
  • congestive heart failure (New York Heart Association [NYHA] III + IV)
  • acute life-threatening cardiovascular disease
  • acute surgical abdominal conditions
  • untreated or uncontrolled arterial hypertension
  • known clinically significant reduced renal function with creatinine > 170 µmol/L
  • known clinically significant reduced liver function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
MOVIPREP
Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy
Other Names:
  • MOVIPREP
ACTIVE_COMPARATOR: 2
Picolax
Drug: NA picosulfate magnesium citrate
150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
Time Frame: within 3 months
within 3 months
taste acceptability
Time Frame: 8 days
8 days
ease of taking, and ability to complete, the bowel preparation treatment
Time Frame: 8 days
8 days
recommended diet compliance
Time Frame: 8 days
8 days
would the patient be prepared to repeat the bowel preparation treatment if necessary?
Time Frame: 8 days
8 days
well-being and effect on usual activities whilst taking the bowel preparation treatment
Time Frame: 8 days
8 days
overall impression of the bowel preparation treatment prior to colonoscopy
Time Frame: 8 days
8 days
symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norgine

Investigators

  • Study Director: Mike Geraint, MD, Norgine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

April 6, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (ESTIMATE)

April 10, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRL994-02-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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