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The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90 grams of Crystalline Lactulose | Drug | 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 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. | 10-14 hours post last consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | Safety determined by the incidence of treatment emergent adverse events. | 1 day post last consumption |
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Krause, MD | ClinSearch, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 90 Grams Crystalline Lactulose | 15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses |
| FG001 | 135 Grams Crystalline Lactulose | 15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses |
| FG002 | 180 Grams Crystalline Lactulose | 15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients adhered to the one set of study-level eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 90 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses |
| BG001 | 135 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 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. | Posted | Mean | Standard Deviation | units on a scale | 10-14 hours post last consumption |
|
Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 90 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, PhD | Cumberland Pharmaceuticals, Inc. | 615-255-0068 | arock@cumberlandpharma.com |
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| 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 |
|
Safety determined by the severity of treatment emergent adverse events.
| 1 day post last consumption |
| Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable | 1 day post last consumption |
| BG002 | 180 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 180 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses |
|
|
| Secondary | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | Safety determined by the incidence of treatment emergent adverse events. | Posted | Number | % of patients with adverse events | 1 day post last consumption |
|
|
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| Secondary | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Safety determined by the severity of treatment emergent adverse events. | Posted | Number | Percentage of subjects | 1 day post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable | Posted | Mean | Standard Deviation | units on a VAS scale | 1 day post last consumption |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | 135 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses | 0 | 12 | 4 | 12 |
| EG002 | 180 Grams of Crystalline Lactulose | 15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses | 0 | 12 | 6 | 12 |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Procedural hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Severe |
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