Colonoscopy Preparation
Conditions
Keywords
Bowel Evacuation, Colonoscopy Preparation
Brief summary
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.
Detailed description
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.
Interventions
DRUGFull dose preparation
DRUGSplit dose preparation
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 work or vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts. * Patients with a history of impaired renal function. * Patients with current or recent history of hypotension, as defined by the Investigator. * Patients with a history of long Q-T syndrome. * Patients with a history of a failed bowel preparation. * Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives. * Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery. * Patients on lactulose therapy or receiving any treatment for chronic constipation. * Be pregnant or nursing. * Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery or argon plasma coagulation). * Patients less than 18 years of age. * Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions. * Be otherwise unsuitable for the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Lactulose as a Preparation for Colonoscopy. | at least 3 hours post last consumption | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS) | 3 - 15 hours post last consumption | 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. |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1 | 3-15 hours post last consumption | 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 |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2 | 3-15 hours post last consumption | 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 |
| Incidence of Treatment Failure | at least 3 hours post last consumption | 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. |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant | 3 - 15 hours post last consumption | 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. |
| Colonic Hydrogen Gas Levels | 3 - 15 hours post last consumption | — |
| Colonic Methane Gas Levels | 3 - 15 hours post last consumption | — |
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3 | 3 - 15 hours post last consumption | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Full Dose Preparation; AM Colonoscopy | Full Dose Preparation: PM Colonoscopy | Split Dose Preparation; AM Colonscopy | Split Dose Preparation; PM Colonoscopy | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 9 Participants | 8 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 10 Participants | 9 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 10 Participants | 9 Participants | 39 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 5 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: at least 3 hours post last consumption
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Efficacy of Lactulose as a Preparation for Colonoscopy. | 8.2 units on a scale | Standard Deviation 0.42 |
| Regimen A for PM Colonoscopy | Efficacy of Lactulose as a Preparation for Colonoscopy. | 7.2 units on a scale | Standard Deviation 1.23 |
| Regimen B for AM Colonoscopy | Efficacy of Lactulose as a Preparation for Colonoscopy. | 7.5 units on a scale | Standard Deviation 1.9 |
| Regimen B for PM Colonoscopy | Efficacy of Lactulose as a Preparation for Colonoscopy. | 8.4 units on a scale | Standard Deviation 1.26 |
Secondary
Colonic Hydrogen Gas Levels
Time frame: 3 - 15 hours post last consumption
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A for AM Colonoscopy | Colonic Hydrogen Gas Levels | Sigmoid colon; start of procedure | 1267 parts per million by volume | Standard Deviation 3158 |
| Regimen A for AM Colonoscopy | Colonic Hydrogen Gas Levels | Cecum | 3637 parts per million by volume | Standard Deviation 11297 |
| Regimen A for AM Colonoscopy | Colonic Hydrogen Gas Levels | Sigmoid colon; end procedure | 314 parts per million by volume | Standard Deviation 329 |
Secondary
Colonic Methane Gas Levels
Time frame: 3 - 15 hours post last consumption
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Regimen A for AM Colonoscopy | Colonic Methane Gas Levels | NA parts per million by volume |
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.
Time frame: at least 3 hours post last consumption
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regimen A for AM Colonoscopy | Incidence of Treatment Failure | 1 participants |
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.
Time frame: 3 - 15 hours post last consumption
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | 93 Percentage of Participants |
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.
Time frame: 3 to 15 hours post last consumption
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Strongly prefer the lactulose | 62 percentage of participants |
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Somewhat prefer the Lactulose | 24 percentage of participants |
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Have no preference | 5 percentage of participants |
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Somewhat prefer the other | 5 percentage of participants |
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant | Strongly prefer the other | 5 percentage of participants |
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
Time frame: 3-15 hours post last consumption
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1 | 6.0 units on Likert Scale | Standard Deviation 1.6 |
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
Time frame: 3-15 hours post last consumption
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2 | 5.5 units on Likert Scale | Standard Deviation 2.1 |
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
Time frame: 3 - 15 hours post last consumption
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3 | 6.8 units on Likert Scale | Standard Deviation 0.9 |
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.
Time frame: 3 - 15 hours post last consumption
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A for AM Colonoscopy | Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS) | 79.6 units on VAS scale | Standard Deviation 17.2 |