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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 healthy
Started Jan 2010
Shorter than P25 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
August 10, 2010
CompletedJuly 12, 2011
July 1, 2011
1 month
February 2, 2010
May 18, 2010
July 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Weighted vs. Unweighted BASA Scale
1 Day
Study Arms (3)
Cholestyramine 4 grams
ACTIVE COMPARATORCholestyramine 12 grams
ACTIVE COMPARATORTang
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Louisville Metabolic and Atherosclerosis Research Centerlead
- Provident Clinical Researchcollaborator
- Daiichi Sankyocollaborator
Study Sites (1)
L-MARC Research Center
Louisville, Kentucky, 40213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
(1)It was performed in generally healthy subjects, for whom lipid-altering medication may not be indicated.(2)The subjects' preference or dislike of the 1st or 2nd powder mixture might have influenced their ratings of the 2nd or 3rd powder.
Results Point of Contact
- Title
- Harold E. Bays, MD
- Organization
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Study Officials
- PRINCIPAL INVESTIGATOR
Harold E Bays, MD
L-MARC Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 4, 2010
Study Start
January 1, 2010
Primary Completion
February 1, 2010
Study Completion
April 1, 2010
Last Updated
July 12, 2011
Results First Posted
August 10, 2010
Record last verified: 2011-07