NCT00312481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

April 6, 2006

Last Update Submit

December 12, 2007

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.

    8 days

Secondary Outcomes (8)

  • 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?

    within 3 months

  • taste acceptability

    8 days

  • ease of taking, and ability to complete, the bowel preparation treatment

    8 days

  • recommended diet compliance

    8 days

  • would the patient be prepared to repeat the bowel preparation treatment if necessary?

    8 days

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

MOVIPREP

Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

2

ACTIVE COMPARATOR

Picolax

Drug: NA picosulfate magnesium citrate

Interventions

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateDRUG

Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy

Also known as: MOVIPREP
1
NA picosulfate magnesium citrateDRUG

150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (2)

  • Hookey LC, Depew WT, Vanner SJ. A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing. Am J Gastroenterol. 2004 Nov;99(11):2217-22. doi: 10.1111/j.1572-0241.2004.40482.x.

    PMID: 15555005BACKGROUND

  • Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.

    PMID: 18179734DERIVED

MeSH Terms

Interventions

MoviPrep

Study Officials

  • Mike Geraint, MD

    Norgine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

July 1, 2005

Study Completion

May 1, 2006

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

GB(1)