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| Name | Class |
|---|---|
| Provident Clinical Research | OTHER |
| Daiichi Sankyo | INDUSTRY |
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The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the accuracy and usefulness of a taste test questionnaire.
The primary objective of this study is to evaluate patient acceptability of 2 doses of orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second objective is to assess the 2 different versions of the BASA scale. One version will be unweighted with the score based upon the aggregate score of each acceptability component. A second version will be weighted based upon subjectively-reported importance of the acceptability components. The one main study objective or focus is to determine which version of a BASA scale best differentiates patient acceptability of a bile acid sequestrant (cholestyramine) versus a placebo control powder (containing no bile acid sequestrant) thereby determining which BASA scale is the best validated instrument for future studies in assessing and comparing patient acceptability of bile acid sequestrants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholestyramine 4 grams | Active Comparator |
| |
| Cholestyramine 12 grams | Active Comparator |
| |
| Tang | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholestyramine | Drug | Cholestyramine 4 grams one time dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale. | The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted vs. Unweighted BASA Scale | The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4. |
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Inclusion Criteria:
Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold E Bays, MD | L-MARC Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
Enrolled subjects were required to meet all of the inclusion and none of the exclusion criteria prior to being randomized to a group assignment. Subjects were also required to undergo vital sign obtainment, a brief physical exam, and a medical history review to ensure they were generally healthy.
Recruitment started in January 2010 and ended in February 2010. Enrollment officially closed on February 25th, 2010. All patient screening and study visits were conducted at L-MARC Research Center's clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholestyramine 4 Grams vs 12 Grams vs Tang | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholestyramine 4 Grams vs 12 Grams vs Tang | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the age characteristics are the same for all three arms. |
| 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 Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale. | The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1. | Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration. | Posted | Mean | Standard Deviation | Units on Scale | 1 Day |
|
Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
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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 | Cholestyramine 4 Grams |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Belching | Gastrointestinal disorders |
(1)It was performed in generally healthy subjects, for whom lipid-altering medication may not be indicated.(2)The subjects' preference or dislike of the 1st or 2nd powder mixture might have influenced their ratings of the 2nd or 3rd powder.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harold E. Bays, MD | Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | 502-515-5672 | HBaysMD@aol.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002792 | Cholestyramine Resin |
| ID | Term |
|---|---|
| D011137 | Polystyrenes |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Cholestyramine | Drug | Cholestyramine 12 grams one dose, one day |
|
|
| Tang | Drug | Tang one dose one day |
|
| 1 Day |
| Count of Participants |
| Participants |
|
| Age Continuous | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the age characteristics are the same for all three arms. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the gender characteristics are the same for all three arms. | Count of Participants | Participants |
|
| Region of Enrollment | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the regions of enrollment are the same for all three arms. | Number | participants |
|
| Total Enrollment Numbers | Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, total enrollment number is reflective of all study subjects who participated in the trial. | Number | Participants |
|
| OG002 | Tang |
|
|
|
| Secondary | Weighted vs. Unweighted BASA Scale | The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4. | Posted | Median | Standard Deviation | Units on Scale | 1 Day |
|
|
|
| 0 |
| 42 |
| 2 |
| 42 |
| EG001 | Cholestyramine 12 Grams | 0 | 42 | 1 | 42 |
| EG002 | Tang | 0 | 42 | 2 | 42 |
| Nausea | Gastrointestinal disorders |
|
| Loose Stool | Gastrointestinal disorders |
|
| Gas | Gastrointestinal disorders |
|
| Urge to have bowel movement | Gastrointestinal disorders |
|
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| D001697 |
| Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
|