Clinical trial NCT01062269: A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
Official title: A Randomized Single Blind Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Bile acid sequestrant
Resin
Cholesterol
Diabetes mellitus
Lipids
Glucose
Bile Acid Sequestrant Acceptability Scale (BASA)validation study
Lead sponsor: Louisville Metabolic and Atherosclerosis Research Center
Sponsor class: OTHER
Collaborators: name: Provident Clinical Research
name: Daiichi Sankyo
First posted: 2010-02-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 Day
Secondary outcomes:
measure: Weighted vs. Unweighted BASA Scale
timeFrame: 1 Day
Other outcomes:
Locations:
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
Study officials:
affiliation: L-MARC Research Center
name: Harold E Bays, MD
role: PRINCIPAL_INVESTIGATOR
References: