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

This study has been completed.
Sponsor:
Collaborators:
Provident Clinical Research
Daiichi Sankyo Inc.
Information provided by:
Louisville Metabolic and Atherosclerosis Research Center
ClinicalTrials.gov Identifier:
NCT01062269
First received: February 2, 2010
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Cholestyramine
Drug: Tang
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Single Blind Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Louisville Metabolic and Atherosclerosis Research Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Weighted vs. Unweighted BASA Scale [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 42
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholestyramine 4 grams Drug: Cholestyramine
Cholestyramine 4 grams one time dose
Other Name: Questran
Active Comparator: Cholestyramine 12 grams Drug: Cholestyramine
Cholestyramine 12 grams one dose, one day
Other Name: Questran
Placebo Comparator: Tang Drug: Tang
Tang one dose one day
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062269

Locations
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
Sponsors and Collaborators
Louisville Metabolic and Atherosclerosis Research Center
Provident Clinical Research
Daiichi Sankyo Inc.
Investigators
Principal Investigator: Harold E Bays, MD L-MARC Research Center
  More Information

No publications provided

Responsible Party: Harold Bays MD, L-MARC Research Center
ClinicalTrials.gov Identifier: NCT01062269     History of Changes
Other Study ID Numbers: OO1
Study First Received: February 2, 2010
Results First Received: May 18, 2010
Last Updated: July 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Louisville Metabolic and Atherosclerosis Research Center:
Bile acid sequestrant
Resin
Cholesterol
Diabetes mellitus
Lipids
Glucose
Bile Acid Sequestrant Acceptability Scale (BASA)validation study

Additional relevant MeSH terms:
Bile Acids and Salts
Cholestyramine Resin
Anticholesteremic Agents
Antimetabolites
Gastrointestinal Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014