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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cholestyramine; Drug: Cholestyramine; Drug: Tang

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cholestyramine 4 grams	Drug: Cholestyramine; Cholestyramine 4 grams one time dose; Other Names: Questran; Drug: Cholestyramine; Cholestyramine 12 grams one dose, one day; Other Names: Questran
ACTIVE_COMPARATOR: Cholestyramine 12 grams	Drug: Cholestyramine; Cholestyramine 4 grams one time dose; Other Names: Questran; Drug: Cholestyramine; Cholestyramine 12 grams one dose, one day; Other Names: Questran
PLACEBO_COMPARATOR: Tang	Drug: Tang; Tang one dose one day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Collaborators and Investigators

• Sponsor: Louisville Metabolic and Atherosclerosis Research Center
• Collaborators: Daiichi Sankyo, Inc.; Provident Clinical Research

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (ESTIMATE): February 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 1, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Cholesterol; Lipids; Diabetes mellitus; Glucose; Resin; Bile acid sequestrant; Bile Acid Sequestrant Acceptability Scale (BASA)validation study
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cholestyramine Resin
• Other Study ID Numbers: OO1