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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Constipation |
| Interventions: |
Drug: lactulose (Kristalose®) Drug: liquid lactulose |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| 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. |
| Powder, Then Liquid Lactulose | Liquid, Then Powder Lactulose | |
|---|---|---|
| STARTED | 23 | 27 |
| COMPLETED | 23 | 27 |
| NOT COMPLETED | 0 | 0 |
| Powder, Then Liquid Lactulose | Liquid, Then Powder Lactulose | |
|---|---|---|
| STARTED | 23 | 27 |
| COMPLETED | 23 | 25 |
| NOT COMPLETED | 0 | 2 |
| Lost to Follow-up | 0 | 2 |
Baseline Characteristics
| Description | |
|---|---|
| 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. |
| Powder, Then Liquid Lactulose | Liquid, Then Powder Lactulose | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
23 | 27 | 50 |
|
Age, Customized
[units: years] Mean ± Standard Deviation |
44.02 ± 13.37 | 52.37 ± 15.71 | 48.61 ± 14.95 |
|
Gender
[units: participants] |
|||
| Female | 18 | 19 | 37 |
| Male | 5 | 8 | 13 |
|
Race/Ethnicity, Customized
[units: participants] |
|||
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 11 | 26 |
| White | 3 | 10 | 13 |
| Hispanic | 4 | 5 | 9 |
| Other | 1 | 0 | 1 |
Outcome Measures
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Cumberland Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00712543 History of Changes |
| Other Study ID Numbers: | KR-001 |
| Study First Received: | July 8, 2008 |
| Results First Received: | April 7, 2011 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Institutional Review Board |