Trial Outcomes & Findings for 2 Regimens of Lactulose for Colonoscopy Preparation in Adults (NCT NCT01887470)

NCT ID: NCT01887470

Last Updated: 2015-06-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: at least 3 hours post last consumption
• Results posted on: 2015-06-01

Participant Flow

Participant milestones

Measure	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.	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.	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.	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.
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 Regimens of Lactulose for Colonoscopy Preparation in Adults

Baseline characteristics by cohort

Measure	Full Dose Preparation; AM Colonoscopy n=10 Participants 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.	Full Dose Preparation: PM Colonoscopy n=10 Participants 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.	Split Dose Preparation; AM Colonscopy n=10 Participants 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 n=10 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	33 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	24 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	39 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=10 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy n=10 Participants Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy n=10 Participants Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy n=10 Participants Regimen B for afternoon colonoscopy Regimen B
Efficacy of Lactulose as a Preparation for Colonoscopy.	8.2 units on a scale Standard Deviation 0.42	7.2 units on a scale Standard Deviation 1.23	7.5 units on a scale Standard Deviation 1.90	8.4 units on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Incidence of Treatment Failure	1 participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
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	—	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1	6.0 units on Likert Scale Standard Deviation 1.6	—	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2	5.5 units on Likert Scale Standard Deviation 2.1	—	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3	6.8 units on Likert Scale Standard Deviation 0.9	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Tolerability of and Preference for Lactulose as a Bowel Evacuant	93 Percentage of Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Survey response to question: "if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=21 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Tolerability of and Preference for Lactulose as a Bowel Evacuant Somewhat prefer the other	5 percentage of participants	—	—	—
Tolerability of and Preference for Lactulose as a Bowel Evacuant Strongly prefer the other	5 percentage of participants	—	—	—
Tolerability of and Preference for Lactulose as a Bowel Evacuant Strongly prefer the lactulose	62 percentage of participants	—	—	—
Tolerability of and Preference for Lactulose as a Bowel Evacuant Somewhat prefer the Lactulose	24 percentage of participants	—	—	—
Tolerability of and Preference for Lactulose as a Bowel Evacuant Have no preference	5 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Colonic Hydrogen Gas Levels Sigmoid colon; start of procedure	1267 parts per million by volume Standard Deviation 3158	—	—	—
Colonic Hydrogen Gas Levels Cecum	3637 parts per million by volume Standard Deviation 11297	—	—	—
Colonic Hydrogen Gas Levels Sigmoid colon; end procedure	314 parts per million by volume Standard Deviation 329	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Regimen A for AM Colonoscopy n=40 Participants Regimen A for morning colonoscopy Regimen A	Regimen A for PM Colonoscopy Regimen A for afternoon colonoscopy Regimen A	Regimen B for AM Colonoscopy Regimen B for morning colonoscopy Regimen B	Regimen B for PM Colonoscopy Regimen B for afternoon colonoscopy Regimen B
Colonic Methane Gas Levels	NA parts per million by volume All values for methane were below the level of detection of the laboratory methods	—	—	—

Adverse Events

Lactulose for Oral Solution

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lactulose for Oral Solution n=40 participants at risk 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.
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	5.0% 2/40 • Number of events 2 • 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.
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • 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.
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypomagnesemia	2.5% 1/40 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypokalemia	2.5% 1/40 • Number of events 1 • 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.

Additional Information

Amy Rock, PhD

Cumberland Pharmaceuticals, Inc.

Phone: 615-255-0068

Email: arock@cumberlandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place