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

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01062269

Run by

Louisville Metabolic and Atherosclerosis Research Center

People needed

42

Starts

2010-01-01

Expected to finish

2010-04-01

Last updated by the study team

2011-07-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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