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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01887470 | 2 Regimens of Lactulose for Colonoscopy Preparation in Adults | PHASE2 | COMPLETED | 55 | — | — | Jul 1, 2013 | Oct 1, 2013 | Jun 1, 2015 | 1 | United States |
Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.
| Arm | Type | Description |
|---|---|---|
| Full dose preparation; AM colonoscopy | EXPERIMENTAL | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. |
| Full dose preparation; PM colonoscopy | EXPERIMENTAL | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. |
| Split dose preparation; AM colonoscopy | EXPERIMENTAL | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. |
| Split dose preparation; PM colonoscopy | EXPERIMENTAL | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon. |
| Name | Type | Description |
|---|---|---|
| Full dose preparation | DRUG | - |
| Split dose preparation | 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 lactulose for oral solution. * Patients with an abnormality on screening blood ...