Gastrointestinal DiseasesPhase 4NORMONCT00605228
A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation
A Phase 4 study testing MOVIPREP and COLOPEG in people with Gastrointestinal Diseases, run by Norgine at 21 sites in France.
Trial summary
Primary: To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy. Secondary: To assess the safety of Moviprep® versus Colopeg®. To assess acceptability of Moviprep® versus Colopeg®. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- MOVIPREP and COLOPEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 21 sitesFrance
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's written informed consent must be obtained prior to inclusion.
- Male or female, outpatients between 18 and 85 years old with an indication to 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 birth control.
Who cannot join
- Age < 18 or > 85 years old,
- Ileus,
- Suspected intestinal occlusion or perforation,
- Toxic megacolon with severe inflammation conditions of intestinal tract (patients with Crohn's Disease or Ulcerative Colitis included),
- Gastroparesis,
- Congestive heart failure NYHA III or IV,
Show all 15Show fewer
- Documented Carcinoma or any other colic disease leading to a fragile mucosa,
- Documented severe renal insufficiency history
- Known hypersensitivity to MoviPrep®, Colopeg® or to any of their components (PEG, ascorbic acid etc.),
- Known deficiency in G6PD and/or phenylketonuria,
- Concurrent participation in an investigational drug/device study or participation within 30 days of study entry,
- Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control,
- Clinically significant laboratory abnormality or disease which, in the opinion of the investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.
- Vulnerable patients (protected by the law) and those admitted to a sanitary/social institution according to Art.L-1121-6 of the French Public Health Code.
- -
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Cabinet de gatsro-entérologie
Anglet, 64600
Cabinet de gastroentérologie
Aubagne, 13400
Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON
Avignon, 84029
Clinique de La Châtaigneraie
Beaumont, 63110
Cabinet de gastro-entérologie
Bordeaux, 33300
Clinique Saint Martin
Caen, 14000
Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL
Créteil, 94000
Centre Des Maladies Du Foie Et de L'Appareil Digestif
Irigny, 69540
Centre Hospitalier Du Mans
Le Mans, Lemans, 72000
Cabinet de gastroentérologie
Les Sables-d'Olonne, 85100
Cabinet Medical Jemmapes
Lille, 59800
Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
Nancy, Nancy, 54511
Service de Gastroentérologie, HOPITAL DE L'ARCHET
Nice, 06200
Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU
Paris, 75015
Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE
Paris, 75475
Hopital F. Mitterand
Pau, 64000
Polyclinique Courlancy
Reims, 51100
Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire
Rennes, 35000
Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
Rouen, Rouen, 76031
Clinique Saint Jean Languedoc
Toulouse, 31400
Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
Tours, 37000
About this study
Official title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.
Primary:
- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.
Secondary:
- To assess the safety of Moviprep® versus Colopeg®.
- To assess acceptability of Moviprep® versus Colopeg®.
Read the detailed description
Primary efficacy analysis will be performed on the ITT population. Secondary efficacy analysis will be performed on both ITT and PP sets. Results will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data listings.
Safety analysis will be performed on the safety set (ITT population). Safety data of all patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).
Acceptability analysis will be performed on the ITT population. Acceptability data of all patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).
- Conditions
- Gastrointestinal Diseases
- Being tested
- MOVIPREP, COLOPEG
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVIPREPDrug
2L Drug
COLOPEGDrug
4L Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MOVIPREP |
| 2 | Active comparator | Not described Receives: Drug: COLOPEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with successful colon cleansing as judged by blinded reviewers on the basis of videotapes recorded during the colonoscopy [the blinded reviewers will grade the colon cleansing only once]
Measured: 1 day
Secondary outcomes (1)
the proportion of patients with successful colon cleansing as judged by the colonoscopist, the colonic segment cleansing score as assessed by the colonoscopist and the blinded reviewers and Aronchick global score as assessed by blinded reviewers.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Investigators
- Thierry PONCHON, MD, Principal investigator, HOPITAL EDOUARD HERRIOT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605228
- Sponsor's protocol ID
- NRL994-02/2006 (FFS)
- Acronym
- NORMO
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bitoun A, Ponchon T, Barthet M, Coffin B, Dugue C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. doi: 10.1111/j.1365-2036.2006.03167.x. Epub 2006 Nov 10.
PubMed 17094774
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.
- ClinicalTrials.gov ID
- NCT00605228
- Acronym / sponsor ID
- NORMO / NRL994-02/2006 (FFS)
- Conditions
- Gastrointestinal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary:
- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.
Secondary:
- To assess the safety of Moviprep® versus Colopeg®.
- To assess acceptability of Moviprep® versus Colopeg®.
Detailed description
Primary efficacy analysis will be performed on the ITT population. Secondary efficacy analysis will be performed on both ITT and PP sets. Results will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data listings.
Safety analysis will be performed on the safety set (ITT population). Safety data of all patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).
Acceptability analysis will be performed on the ITT population. Acceptability data of all patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MOVIPREP |
| 2 | Active comparator | Drug: COLOPEG |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient's written informed consent must be obtained prior to inclusion.
- Male or female, outpatients between 18 and 85 years old with an indication to 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 birth control.
Key exclusion criteria (15 listed)
- Age < 18 or > 85 years old,
- Ileus,
- Suspected intestinal occlusion or perforation,
- Toxic megacolon with severe inflammation conditions of intestinal tract (patients with Crohn's Disease or Ulcerative Colitis included),
- Gastroparesis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVIPREP2L Drug | Drug | 1 |
| COLOPEG4L Drug | Drug | 2 |
Primary outcome
the proportion of patients with successful colon cleansing as judged by blinded reviewers on the basis of videotapes recorded during the colonoscopy [the blinded reviewers will grade the colon cleansing only once]
Time frame: 1 day
1 secondary outcome
the proportion of patients with successful colon cleansing as judged by the colonoscopist, the colonic segment cleansing score as assessed by the colonoscopist and the blinded reviewers and Aronchick global score as assessed by blinded reviewers.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
- Background: PubMed 17094774Bitoun A, Ponchon T, Barthet M, Coffin B, Dugue C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. doi: 10.1111/j.1365-2036.2006.03167.x. Epub 2006 Nov 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PONCHON, MD principal investigator
HOPITAL EDOUARD HERRIOT
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MOVIPREP and COLOPEG in people with Gastrointestinal Diseases, run by Norgine at 21 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 4 inclusion and 15 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 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the proportion of patients with successful colon cleansing as judged by blinded reviewers on the basis of videotapes recorded during the colonoscopy [the blinded reviewers will grade the colon cleansing only once] (time frame: 1 day). 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 NCT00605228, 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 30 Jan 2008; AzTrials last refreshed its copy on 6 Nov 2026.