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This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Kristalose®, as prescribed, for 7 days. |
|
| 2 | Experimental | Liquid lactulose, as prescribed, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lactulose (Kristalose®) | Drug | Crystals to be dissolved in water and taken as prescribed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arya Gastroenterology Associates | Brooklyn | New York | 11237 | United States | ||
| Wake Research Associates |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Powder, Then Liquid Lactulose | Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days. |
| FG001 | Liquid, Then Powder Lactulose | Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1-7 |
| |||||||||||||
| Day 8-14 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Powder, Then Liquid Lactulose | Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days. |
| BG001 | Liquid, Then Powder Lactulose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. | Posted | Apr 2011 | Number | participants | 14 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Powder, Then Liquid Lactulose | Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Voss, Ph.D. | Cumberland Pharmaceuticals Inc. | 615-255-0068 | bvoss@cumberlandpharma.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| liquid lactulose | Drug | Liquid to be taken as prescribed. |
|
| Raleigh |
| North Carolina |
| 27612 |
| United States |
| Rapid Medical Research | Cleveland | Ohio | 44122 | United States |
| NOT COMPLETED |
|
|
Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 50 |
| 13 |
| 50 |
| EG001 | Liquid, Then Powder Lactulose | Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days. | 0 | 50 | 10 | 50 |
| Abdominal distention | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abdominal pain, upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abdominal pain, lower | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pharyngoleryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Menstrual cramps | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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| D000073893 |
| Sugars |