Phase 3
N=140
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Bottom Line
View on ClinicalTrials.gov: NCT01732692 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With Successful Colon Cleansing — 94.29; 91.43 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MOVIPREP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Colon Cleansing |
94.29; 91.43 | <0.001 sig |
| SECONDARY Patient Satisfaction of Colonoscopy Preparation (VAS) |
81.2; 79.6 | — |
| SECONDARY Total Compliance Score |
98.1; 99.5 | — |
| SECONDARY Patient Compliance - Amount of Additional Clear Liquid Consumed |
545.43; 640.29; 539.71; 585.65 | — |
| SECONDARY Percentage of Patients Who Experienced Adverse Events (AEs) |
58.6; 61.4; 52.9; 54.3; 5.7; 7.1 | — |
Summary
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
Eligibility Criteria
Inclusion Criteria
- male or female ≥18 years and ≤ 85 years
- colonoscopy procedure indicated
- willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion
- willing and able to undergo study-related procedures
- informed consent signed by a patient for participation in the study
- negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study
Exclusion Criteria
- ileus
- suspected colonic tumor with manifestations of intestinal obstruction
- delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation
- toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis
- suspected intestinal perforation or risk of gastrointestinal perforation
- signs of severe intestinal bleeding
- acute inflammatory anal or perianal pathology
- severe concomitant diseases of internal organs
- psychiatric diseases in aggravation stage
- hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation
- phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency
- unconsciousness
- dehydration
- severe inflammatory diseases
- acute abdominal pain of unknown etiology
- pregnancy and lactation period
- participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial
- patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)
- any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data
Data sourced from ClinicalTrials.gov (NCT01732692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.