Constipation
Conditions
Keywords
constipation, laxative, lactulose, Kristalose®
Brief summary
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Detailed description
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Interventions
DRUGlactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
DRUGliquid lactulose
Liquid to be taken as prescribed.
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with recently diagnosed chronic constipation requiring treatment.
Exclusion criteria
* Patients with galactosemia (galactose-sensitive diet). * Patients less than 18 years of age. * Patients currently on lactulose therapy. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | 14 days |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Powder, Then Liquid Lactulose Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days. | 23 |
| Liquid, Then Powder Lactulose Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days. | 27 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Day 8-14 | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Liquid, Then Powder Lactulose | Total | Powder, Then Liquid Lactulose |
|---|---|---|---|
| Age, Customized | 52.37 years STANDARD_DEVIATION 15.71 | 48.61 years STANDARD_DEVIATION 14.95 | 44.02 years STANDARD_DEVIATION 13.37 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 11 participants | 26 participants | 15 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants | 9 participants | 4 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 10 participants | 13 participants | 3 participants |
| Sex: Female, Male Female | 19 Participants | 37 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 50 | 10 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose overall | 12 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of consistency | 7 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of taste | 7 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of consistency | 11 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose overall | 7 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of consistency | 5 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of taste | 12 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of portability | 1 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference overall | 4 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of portability | 17 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of portability | 5 participants |
| Powder, Then Liquid Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of taste | 4 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of portability | 5 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose overall | 6 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose overall | 11 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference overall | 8 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of taste | 9 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of taste | 11 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of taste | 5 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of consistency | 7 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of consistency | 11 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | No preference in terms of consistency | 7 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred liquid lactulose in terms of portability | 4 participants |
| Liquid, Then Powder Lactulose | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Preferred powder lactulose in terms of portability | 16 participants |