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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01256541 | Kristalose as Bowel Evacuant Prior to Colonoscopy | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2010 | Sep 1, 2011 | Oct 6, 2011 | 1 | United States |
To evaluate the primary objective of hydrogen and methane gas production as measured by: • Pre- and post-dose breath analysis for hydrogen and methane gas.
| Arm | Type | Description |
|---|---|---|
| Kristalose | EXPERIMENTAL | Kristalose as Bowel Evacuant |
| Name | Type | Description |
|---|---|---|
| Kristalose | DRUG | The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
Inclusion Criteria: Patients requiring bowel evacuation for colonoscopy Exclusion Criteria: 1. Patients with galactosemia (galactose-sensitive diet). 2. Patients known to be hypersensitive to any of the components of Kristalose. 3. Patients with possible bowel obstruction, previous colonic surger...