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ColonoscopyPhase 3NCT00322062

MOVIPREP® Versus NaP Pivotal Phase III Study

A Phase 3 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and Sodium Phosphate Solution in people with Colonoscopy, run by Norgine at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colonoscopy
What is being tested?
macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and Sodium Phosphate Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
18 sitesFrance
Study dates
Apr 2002to Mar 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female, out and inpatients to be at least 18 years old and <75 years old sent to the endoscopic ward for diagnostic or therapeutic colonoscopy
  • willing and able to complete the entire procedure and to comply with study instructions
  • females of childbearing potential must employ an adequate method of contraception.

Who cannot join

  • age <18 or > 75 years old
  • ileus
  • suspected intestinal occlusion or perforation
  • toxic or congenital megacolon
  • history of colonic resection
  • patients with Crohn's disease or ulcerative colitis
Show all 12Show fewer
  • congestive heart failure NYHA III or IV
  • documented renal insufficiency history with creatinine >170µmol/l
  • known hypersensitivity to polyethylene glycols or Na phosphate and/or vitamin C
  • concurrent participation in an investigational drug study or participation within 90 days of study entry
  • females who are pregnant, or planning a pregnancy. Females of childbearing potential not using reliable methods of contraception
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Mourier

    Colombes, 92700

  • Hôpital Huriez

    Lille, 59037

  • Hôpital Dupuytren

    Limoges, 87000

  • Hôpital Edouard Herriot

    Lyon, 69003

  • Hôpital Nord

    Marseille Nord Cedex 20, 13915

  • Centre Hospitalier

    Montélimar, 26216

  • Centre Hospitalier Intercommunal

    Montfermeil, 93370

  • Centre Hospitalier De Montpellier Hôpital St Eloi

    Montpellier, 34000

  • Hôpital De L'Archet

    Nice, 06202

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hôpital Croix Saint Simon

    Paris, 75020

  • Hôpital Cochin

    Paris, 75379

  • Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré

    Paris, 75475

  • Hôpital Civil / Clinique Medical B

    Strasbourg, 67091

  • Hôpital Rangueil

    Toulouse, 31403

  • Hôpital Trousseau CHRU

    Tours, 37000

  • CHU De Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

Read the detailed description

Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy. Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be randomised. One of the two tested products will be delivered by a pharmacist, blindly from the gastroenterologist. The assigned product will be taken the day before the coloscopy according to the information leaflet. Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading i.e. "the overall quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning, before the coloscopy.

After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last visit is performed.

Conditions
Colonoscopy
Being tested
macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate, Sodium Phosphate Solution
Keywords
Colon cleansing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateDrug

    Also called MOVIPREP®

    2L gut lavage solution

  • Sodium Phosphate SolutionDrug

    Also called Fleet Phospho Soda®

    1 x 45ml solution, BID

Study groups in NCT00322062
Study groupRoleWhat they receive
1Experimental1 pack (contains 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets)= 2L NRL994 . 2 sachets (one of each) will be dissolved in 1L of water. Each litre will be drunk within 1 hour. Furthermore, at least 1000ml (or more) of any additional clear fluid (except milk) has to be drunk after the 2L of NRL994.
Receives: Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
2Active comparator1 pack consists of 2 flasks of 45ml. Each flask has to be dissolved within 125ml of water. Each intake of NaP solution has to be preceded and followed by 250ml (or more if necessary)of clear liquids(excluding milk)and a delay of at least 12 hours between the intake of the 2 x 45ml of NaP solution has to be completed. In addition, 750ml more of clear liquids (excluding milk)or more if needed must be drunk between the 2 intakes.
Receives: Drug: Sodium Phosphate Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficacy will be measured and graded using video-taped record of each colonoscopy for cleansing in a 0 - 4 grade scale for each of the predefined colon areas by an endoscopist.

  2. Grades A or B means a good or correct preparation and are considered as a success whilst C or D are considered as a failed preparation.

Secondary outcomes (3)

  1. evaluation of the preparation quality using a visual analogue scale

  2. recording adverse events and clinical tolerance

  3. patient satisfaction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2006 (estimated)
  2. Study startApr 2002
  3. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00322062
Sponsor's protocol ID
NRL994-02/2001
Status last verified
Apr 2008
First submitted
2 May 2006
Last updated
16 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6. doi: 10.1016/0016-5085(90)91284-d.

    PubMed 2293568

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and Sodium Phosphate Solution in people with Colonoscopy, run by Norgine at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy will be measured and graded using video-taped record of each colonoscopy for cleansing in a 0 - 4 grade scale for each of the predefined colon areas by an endoscopist.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2008.

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