A Phase 4 interventional study of MOVIPREP and COLOPEG in Gastrointestinal Diseases, sponsored by Norgine. Completed at 21 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-01-30.
Sponsored by Norgine · Phase 4, Interventional, and Treatment
Primary:
Secondary:
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).
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 400 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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Drug: MOVIPREP
Drug: COLOPEG
2L Drug
4L Drug
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
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
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Norgine