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The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full dose preparation | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Lactulose as a Preparation for Colonoscopy. | 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. | at least 3 hours post last consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Failure | A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0. | at least 3 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Krause, M.D | 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 | Full Dose Preparation; AM Colonoscopy | Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon. |
| FG001 | Full Dose Preparation; PM Colonoscopy | Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon. |
| FG002 | Split Dose Preparation; AM Colonoscopy | 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. |
| FG003 | Split Dose Preparation; PM Colonoscopy | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Dose Preparation; AM Colonoscopy | Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon. |
| BG001 | Full Dose Preparation: PM Colonoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Lactulose as a Preparation for Colonoscopy. | 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. | Posted | Mean | Standard Deviation | units on a scale | at least 3 hours post last consumption |
|
through one day following study drug consumption
The safety endpoint defined in the protocol collected adverse events for all patients taking the investigational product. Comparisons between treatment groups were not intended according to the statistical plan and results are reported as one group.
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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 | Lactulose for Oral Solution | All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 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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| Split dose preparation | Drug |
|
A paper questionnaire contained a horizontal line 100 mm long with the right end labeled "Best Possible Experience" and the left end labeled "Worst Possible Experience". The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation. Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation. |
| 3 - 15 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1 | Tolerability assessed by a patient questionnaire - Likert response to "was regimen a tolerable bowel prep?" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3-15 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2 | Tolerability assessed by a patient questionnaire - Likert response to "I did not experience too much discomfort during the bowel prep" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3-15 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3 | Tolerability assessed by a patient questionnaire - Likert response to "The dosing instructions were easy to understand and follow" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3 - 15 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: "Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied "Yes" to this survey question. | 3 - 15 hours post last consumption |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: "if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications. | 3 to 15 hours post last consumption |
| Colonic Hydrogen Gas Levels | 3 - 15 hours post last consumption |
| Colonic Methane Gas Levels | 3 - 15 hours post last consumption |
Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon. |
| BG002 | Split Dose Preparation; AM Colonscopy | 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. |
| BG003 | Split Dose Preparation; PM Colonoscopy | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Regimen A for PM Colonoscopy | Regimen A for afternoon colonoscopy Regimen A |
| OG002 | Regimen B for AM Colonoscopy | Regimen B for morning colonoscopy Regimen B |
| OG003 | Regimen B for PM Colonoscopy | Regimen B for afternoon colonoscopy Regimen B |
|
|
| Secondary | Incidence of Treatment Failure | A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0. | The study objectives in the protocol called for the incidence of treatment failures to be calculated from the pooled data of all treatment participants. Therefore, outcome measures are not displayed with respect to individual treatment groups. | Posted | Number | participants | at least 3 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS) | A paper questionnaire contained a horizontal line 100 mm long with the right end labeled "Best Possible Experience" and the left end labeled "Worst Possible Experience". The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation. Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation. | The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Standard Deviation | units on VAS scale | 3 - 15 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1 | Tolerability assessed by a patient questionnaire - Likert response to "was regimen a tolerable bowel prep?" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Standard Deviation | units on Likert Scale | 3-15 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2 | Tolerability assessed by a patient questionnaire - Likert response to "I did not experience too much discomfort during the bowel prep" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Standard Deviation | units on Likert Scale | 3-15 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3 | Tolerability assessed by a patient questionnaire - Likert response to "The dosing instructions were easy to understand and follow" Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Standard Deviation | units on Likert Scale | 3 - 15 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: "Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied "Yes" to this survey question. | The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Number | Percentage of Participants | 3 - 15 hours post last consumption |
|
|
|
| Secondary | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: "if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications. | Of the 40 participants responding to the patient questionnaire, only 21 reported that they had had a previous colonoscopy; therefore, the other 19 are not included in this outcome measure. | Posted | Number | percentage of participants | 3 to 15 hours post last consumption |
|
|
|
| Secondary | Colonic Hydrogen Gas Levels | A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Standard Deviation | parts per million by volume | 3 - 15 hours post last consumption |
|
|
|
| Secondary | Colonic Methane Gas Levels | A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups. | Posted | Mean | Full Range | parts per million by volume | 3 - 15 hours post last consumption |
|
|
|
| 0 |
| 40 |
| 7 |
| 40 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Somewhat prefer the other |
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| Strongly prefer the other |
|
| Title | Measurements |
|---|
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