NCT01062269

A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study

A Randomized Single Blind Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Louisville Metabolic and Atherosclerosis Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cholestyramine	Cholestyramine 4 grams one time dose
DRUG	Cholestyramine	Cholestyramine 12 grams one dose, one day
DRUG	Tang	Tang one dose one day

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2010-02-04
• Last updated: 2011-07-12
• Results posted: 2010-08-10

Locations

1 site across 1 country: United States