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MOVIPREP® Versus PICOLAX® Pilot Study

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ClinicalTrials.gov Identifier: NCT00312481
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : December 17, 2007
Sponsor:
Information provided by:
Norgine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colonoscopy Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate Drug: NA picosulfate magnesium citrate Phase 2

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®.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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®)
Study Start Date : July 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: 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.




Primary Outcome Measures :
  1. Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon. [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. taste acceptability [ Time Frame: 8 days ]
  3. ease of taking, and ability to complete, the bowel preparation treatment [ Time Frame: 8 days ]
  4. recommended diet compliance [ Time Frame: 8 days ]
  5. would the patient be prepared to repeat the bowel preparation treatment if necessary? [ Time Frame: 8 days ]
  6. well-being and effect on usual activities whilst taking the bowel preparation treatment [ Time Frame: 8 days ]
  7. overall impression of the bowel preparation treatment prior to colonoscopy [ Time Frame: 8 days ]
  8. symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312481


Locations
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United Kingdom
John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Norgine
Investigators
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Study Director: Mike Geraint, MD Norgine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Mike Geraint, Norgine
ClinicalTrials.gov Identifier: NCT00312481     History of Changes
Other Study ID Numbers: NRL994-02-2004
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: December 17, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
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Ascorbic Acid
Magnesium citrate
Picosulfate sodium
Polyethylene glycol 3350
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Cathartics
Gastrointestinal Agents
Laxatives