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| Name | Class |
|---|---|
| Provident Clinical Research | OTHER |
| Daiichi Sankyo | INDUSTRY |
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The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.
In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholestyramine 12 grams | Active Comparator | Cholestyramine 12 grams |
|
| Colesevelam HCl | Active Comparator | Colesevelam HCl, 4 grams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholestyramine | Drug | Cholestyramine 12 grams, one time dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. | The bile acid sequestrant acceptability (BASA) 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 for each category is 1. | 1 Day |
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| Measure | Description | Time Frame |
|---|---|---|
| Weighted vs. Unweighted Composite BASA Scale Scores | Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4. | 1 Day |
Inclusion Criteria:
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 exlusion 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 April 2010 and ended in May 2010. Enrollment officially closed on May 24th, 2010. All patient screening and study visits were conducted at L-MARC Research Center's clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colesevelam HCl 3.75g First, Then Cholestyramine 12g | Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart. |
| FG001 | Cholestyramine 12g First, Then Colesevelam HCl 3.75 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Colesevelam HCl | Drug | Colesevelam HCl, 4 grams, one time dose |
|
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Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Colesevelam HCl (3.75g) vs Cholestyramine (12g) | Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. | The bile acid sequestrant acceptability (BASA) 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 for each category is 1. | Posted | Mean | Standard Deviation | Units on BASA Scale | 1 Day |
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| Other Pre-specified | Weighted vs. Unweighted Composite BASA Scale Scores | Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4. | Posted | Mean | Standard Deviation | Units on a BASA Scale | 1 Day |
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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 (12g) | Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms. | 0 | 42 | 2 | 42 | ||
| EG001 | Colesevelam HCl (3.75 Grams) | 0 | 42 | 3 | 42 | |||
| EG002 | More Than 30 Minutes After Last Beverage | This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant. | 0 | 42 | 14 | 42 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Belching | Gastrointestinal disorders |
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| Burping | Gastrointestinal disorders |
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| Dry Throat | General disorders |
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| Headache | General disorders |
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| Mild Indigestion | Gastrointestinal disorders |
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| Mild Nausea | Gastrointestinal disorders |
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| Abdominal Cramps | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Gas | Gastrointestinal disorders |
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| Increased Urination | Renal and urinary disorders |
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| Intermittent R Back Thigh Pain | Musculoskeletal and connective tissue disorders |
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| Moderate Indigestion | Gastrointestinal disorders |
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| Severe Indigestion | Gastrointestinal disorders |
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| Moderate Nausea | Gastrointestinal disorders |
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| Vomitting | Gastrointestinal disorders |
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| Bloating | Gastrointestinal disorders |
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Used generally healthy subjects, for who lipid-altering medication may not be indicated; Compared the BAS on the same day; Evaluated estimated equal cholesterol lowering doses of each BAS, rather than same g amt of active drug
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harold E. Bays, MD | Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | 502-515-5672 | kschmitz@lmarc.com |
| 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 |
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D011137 | Polystyrenes |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Appearance Score |
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| Mixability Score |
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| No |
| Superiority or Other |
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