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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02123017 | Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy | PHASE2 | COMPLETED | 32 | — | — | Apr 1, 2014 | Aug 1, 2014 | Feb 24, 2016 | 1 | United States |
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
| Arm | Type | Description |
|---|---|---|
| 90 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses |
| 135 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses |
| 180 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses |
| Name | Type | Description |
|---|---|---|
| 90 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses |
| 135 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses |
| 180 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses |
Inclusion Criteria: * Patients requiring bowel evacuation for colonoscopy. Exclusion Criteria: * Patients with galactosemia (galactose-sensitive diet). * Patients known to be hypersensitive to any of the components of lactulose for oral solution. * Patients with a known abnormality on screening o...