A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomized Single Blind Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects|
- 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. [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]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.
- Weighted vs. Unweighted BASA Scale [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Cholestyramine 4 grams||
Cholestyramine 4 grams one time dose
Other Name: Questran
|Active Comparator: Cholestyramine 12 grams||
Cholestyramine 12 grams one dose, one day
Other Name: Questran
|Placebo Comparator: Tang||
Tang one dose one day
Other Name: Tang
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062269
|United States, Kentucky|
|L-MARC Research Center|
|Louisville, Kentucky, United States, 40213|
|Principal Investigator:||Harold E Bays, MD||L-MARC Research Center|