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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
| Cumberland Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalline Lactulose | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Cleanliness of the Colon During Colonoscopy | 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. | Day of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failures | To evaluate the secondary objective of efficacy, the following endpoint will be measured: o The number and percentage of patient's who by the physician's determination are considered treatment failures (patients with insufficient evacuation of the bowel=Boston bowel prep score < 5, and/or any colon segment score of 0). | Day of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otto Lin, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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| Patient Tolerability and Preference | To evaluate the secondary objective of patient tolerability and preference on the basis of the following assessments: Patient tolerability and preference questionnaire including 100 mm Visual Analog Scale (VAS) and Likert Scale | Day before and day of colonoscopy |
| Colonic Hydrogen and Methane Gas Production | To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by: o Colonic hydrogen and methane gas levels. | Day of colonoscopy |
| Safety/Adverse Events | To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events | Day before colonoscopy till 7 days after colonoscopy |