Healthy
Conditions
Keywords
Bile acid sequestrant, Resin, Cholesterol, Diabetes mellitus, Lipids, Glucose, Bile Acid Sequestrant Acceptability Scale (BASA)validation study
Brief summary
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.
Detailed description
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.
Interventions
DRUGCholestyramine
Cholestyramine 4 grams one time dose
DRUGTang
Tang one dose one day
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
Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period: * Men or women 18-70 years of age * In general good health. * 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 * 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 gall bladder disease * 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 * Blood donation within 8 weeks of the study or anticipation of blood donation during the study. * Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 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 Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale. | 1 Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted vs. Unweighted BASA Scale | 1 Day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Cholestyramine 4 Grams vs 12 Grams vs Tang |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age Continuous | 51.2 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 26 Participants |
| Total Enrollment Numbers | 42 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 | 1 / 42 | 2 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 42 |
Outcome results
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.
Time frame: 1 Day
Population: Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cholestyramine 4 Grams | 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. | Appearance Score | 2.8 Units on Scale | Standard Deviation 0.1 |
| Cholestyramine 4 Grams | 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. | Taste Score | 2.7 Units on Scale | Standard Deviation 0.1 |
| Cholestyramine 4 Grams | 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. | Mixability Score | 2.5 Units on Scale | Standard Deviation 0.1 |
| Cholestyramine 4 Grams | 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. | Texture Score | 2.4 Units on Scale | Standard Deviation 0.2 |
| Cholestyramine 12 Grams | 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. | Appearance Score | 2.8 Units on Scale | Standard Deviation 0.1 |
| Cholestyramine 12 Grams | 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. | Texture Score | 2.0 Units on Scale | Standard Deviation 0.2 |
| Cholestyramine 12 Grams | 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. | Mixability Score | 2.1 Units on Scale | Standard Deviation 0.2 |
| Cholestyramine 12 Grams | 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. | Taste Score | 2.5 Units on Scale | Standard Deviation 0.1 |
| Tang | 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. | Mixability Score | 4.1 Units on Scale | Standard Deviation 0.1 |
| Tang | 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. | Taste Score | 4.2 Units on Scale | Standard Deviation 0.1 |
| Tang | 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. | Texture Score | 4.3 Units on Scale | Standard Deviation 0.2 |
| Tang | 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. | Appearance Score | 4.1 Units on Scale | Standard Deviation 0.1 |
Comparison: The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations.p-value: <0.05measures analysis of variance
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Cholestyramine 4 Grams | Weighted vs. Unweighted BASA Scale | Total BASA Score | 10.3 Units on Scale | Standard Deviation 0.4 |
| Cholestyramine 4 Grams | Weighted vs. Unweighted BASA Scale | Weighted BASA Score | 24.8 Units on Scale | Standard Deviation 1.3 |
| Cholestyramine 12 Grams | Weighted vs. Unweighted BASA Scale | Total BASA Score | 9.4 Units on Scale | Standard Deviation 0.4 |
| Cholestyramine 12 Grams | Weighted vs. Unweighted BASA Scale | Weighted BASA Score | 22.6 Units on Scale | Standard Deviation 1.2 |
| Tang | Weighted vs. Unweighted BASA Scale | Total BASA Score | 16.7 Units on Scale | Standard Deviation 0.5 |
| Tang | Weighted vs. Unweighted BASA Scale | Weighted BASA Score | 41.3 Units on Scale | Standard Deviation 1.8 |