Trial Outcomes & Findings for A Preference Study Comparing Kristalose® and Liquid Lactulose (NCT NCT00712543)
NCT ID: NCT00712543
Last Updated: 2011-09-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
14 days
Results posted on
2011-09-27
Participant Flow
Participants recruited from the outpaient clinics of Wake Research Associates (Raleigh, NC); Rapid Medical Research (Cleveland, OH) and Arya Gastroenterology (Brooklyn, NY) between June 2009 and August 2009.
Participant milestones
| Measure |
Powder, Then Liquid Lactulose
Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
|
Liquid, Then Powder Lactulose
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
|
|---|---|---|
|
Day 1-7
STARTED
|
23
|
27
|
|
Day 1-7
COMPLETED
|
23
|
27
|
|
Day 1-7
NOT COMPLETED
|
0
|
0
|
|
Day 8-14
STARTED
|
23
|
27
|
|
Day 8-14
COMPLETED
|
23
|
25
|
|
Day 8-14
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Powder, Then Liquid Lactulose
Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
|
Liquid, Then Powder Lactulose
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
|
|---|---|---|
|
Day 8-14
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
A Preference Study Comparing Kristalose® and Liquid Lactulose
Baseline characteristics by cohort
| Measure |
Powder, Then Liquid Lactulose
n=23 Participants
Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
|
Liquid, Then Powder Lactulose
n=27 Participants
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
44.02 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
52.37 years
STANDARD_DEVIATION 15.71 • n=7 Participants
|
48.61 years
STANDARD_DEVIATION 14.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Powder, Then Liquid Lactulose
n=23 Participants
Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
|
Liquid, Then Powder Lactulose
n=27 Participants
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
|
|---|---|---|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
No preference in terms of consistency
|
5 participants
|
7 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred liquid lactulose overall
|
7 participants
|
6 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred powder lactulose overall
|
12 participants
|
11 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
No preference overall
|
4 participants
|
8 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred liquid lactulose in terms of taste
|
7 participants
|
9 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred powder lactulose in terms of taste
|
12 participants
|
11 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
No preference in terms of taste
|
4 participants
|
5 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred liquid lactulose in terms of consistency
|
7 participants
|
7 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred powder lactulose in terms of consistency
|
11 participants
|
11 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred liquid lactulose in terms of portability
|
1 participants
|
4 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Preferred powder lactulose in terms of portability
|
17 participants
|
16 participants
|
|
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
No preference in terms of portability
|
5 participants
|
5 participants
|
Adverse Events
Powder, Then Liquid Lactulose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Liquid, Then Powder Lactulose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Powder, Then Liquid Lactulose
n=50 participants at risk
Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
|
Liquid, Then Powder Lactulose
n=50 participants at risk
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
14.0%
7/50 • Number of events 7
|
12.0%
6/50 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal distention
|
6.0%
3/50 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain, lower
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
2/50 • Number of events 2
|
0.00%
0/50
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Headache
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngoleryngeal pain
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Menstrual cramps
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place