Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01732692 | 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 | PHASE3 | COMPLETED | 140 | — | — | Nov 1, 2012 | Apr 1, 2013 | May 15, 2014 | 3 | Kazakhstan, Russia |
Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.
| Arm | Type | Description |
|---|---|---|
| MOVIPREP (Morning-only dose) | EXPERIMENTAL | MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy. |
| MOVIPREP (Split-dose) | OTHER | MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy. |
| Name | Type | Description |
|---|---|---|
| MOVIPREP | DRUG | MOVIPREP solution |
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 participat...