Healthy
Conditions
Keywords
Bile Acid Sequestrant, Resin, Lipids, Glucose, Cholesterol, Diabetes Mellitus, Bile Acid Sequestrant Acceptability Scale
Brief summary
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.
Detailed description
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
Interventions
DRUGCholestyramine
Cholestyramine 12 grams, one time dose
DRUGColesevelam HCl
Colesevelam HCl, 4 grams, one time dose
Sponsors
Provident Clinical Research
Daiichi Sankyo
Louisville Metabolic and Atherosclerosis Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women 18-70 years of age * In general good health (defined as study participants who are medically stable, meet protocol criteria, but who may also have non-exclusionary ongoing medical conditions). * Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf. * Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit.
Exclusion criteria
* Prior intolerance to bile acid sequestrants * Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose. * Women who are either pregnant, or who are not practicing any form of birth control. * Prior gastrointestinal surgery * History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea) * History of bowel obstruction, malabsorption, or irritable bowel syndrome * History of esophageal disease * Current or past history of gallbladder disease * History of pancreatitis * Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit 1. * Diagnosis of diabetes mellitus * Known history of triglyceride levels \> 300 mg/dl. * History of alcohol or drug abuse within 1 year of study entry * Alcohol intake that exceeds more than 2 units of alcohol drinks per day * Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 days of visit 1). * Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 Day | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weighted vs. Unweighted Composite BASA Scale Scores | 1 Day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Colesevelam HCl (3.75g) vs Cholestyramine (12g) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age Continuous | 49.98 years STANDARD_DEVIATION 1.61 |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 42 | 3 / 42 | 14 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 42 |
Outcome results
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colesevelam HCl (3.75g) | 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. | Texture Score | 2.62 Units on BASA Scale | Standard Deviation 0.19 |
| Colesevelam HCl (3.75g) | 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. | Appearance Score | 2.69 Units on BASA Scale | Standard Deviation 0.12 |
| Colesevelam HCl (3.75g) | 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. | Mixability Score | 2.74 Units on BASA Scale | Standard Deviation 0.14 |
| Colesevelam HCl (3.75g) | 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. | Taste Score | 3.26 Units on BASA Scale | Standard Deviation 0.17 |
| Cholestyramine (12g) | 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. | Mixability Score | 2.6 Units on BASA Scale | Standard Deviation 0.14 |
| Cholestyramine (12g) | 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. | Taste Score | 2.67 Units on BASA Scale | Standard Deviation 0.18 |
| Cholestyramine (12g) | 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. | Appearance Score | 3.48 Units on BASA Scale | Standard Deviation 0.15 |
| Cholestyramine (12g) | 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. | Texture Score | 2.36 Units on BASA Scale | Standard Deviation 0.19 |
Comparison: The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed.p-value: <0.05repeated measures analysis of variance
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colesevelam HCl (3.75g) | Weighted vs. Unweighted Composite BASA Scale Scores | Total BASA Score | 11.31 Units on a BASA Scale | Standard Deviation 0.4 |
| Colesevelam HCl (3.75g) | Weighted vs. Unweighted Composite BASA Scale Scores | Total Weighted BASA Score | 27.29 Units on a BASA Scale | Standard Deviation 1.21 |
| Cholestyramine (12g) | Weighted vs. Unweighted Composite BASA Scale Scores | Total BASA Score | 11.10 Units on a BASA Scale | Standard Deviation 0.43 |
| Cholestyramine (12g) | Weighted vs. Unweighted Composite BASA Scale Scores | Total Weighted BASA Score | 26.05 Units on a BASA Scale | Standard Deviation 1.34 |