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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01650870 | Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults | PHASE2 | COMPLETED | 40 | — | — | Jul 1, 2012 | Sep 1, 2012 | Aug 8, 2014 | 1 | United States |
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
| Arm | Type | Description |
|---|---|---|
| Evening Only (full-dose) | ACTIVE_COMPARATOR | The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
| Split-dose | EXPERIMENTAL | The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure. |
| Name | Type | Description |
|---|---|---|
| Crystalline Lactulose | DRUG | - |
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 Crystalline Lactulose * Patients with a history of a failed bowel preparation * P...