Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01062269
Recruitment Status : Completed
First Posted : February 4, 2010
Results First Posted : August 10, 2010
Last Update Posted : July 12, 2011
Sponsor:
Collaborators:
Provident Clinical Research
Daiichi Sankyo, Inc.
Information provided by:
Louisville Metabolic and Atherosclerosis Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Cholestyramine
Drug: Tang
Enrollment 42
Recruitment Details Recruitment started in January 2010 and ended in February 2010. Enrollment officially closed on February 25th, 2010. All patient screening and study visits were conducted at L-MARC Research Center's clinic.
Pre-assignment Details Enrolled subjects were required to meet all of the inclusion and none of the exclusion criteria prior to being randomized to a group assignment. Subjects were also required to undergo vital sign obtainment, a brief physical exam, and a medical history review to ensure they were generally healthy.
Arm/Group Title Cholestyramine 4 Grams vs 12 Grams vs Tang
Hide Arm/Group Description Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
Period Title: Overall Study
Started 42
Completed 42
Not Completed 0
Arm/Group Title Cholestyramine 4 Grams vs 12 Grams vs Tang
Hide Arm/Group Description Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  95.2%
>=65 years
2
   4.8%
[1]
Measure Description: Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the age characteristics are the same for all three arms.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
51.2  (10.1)
[1]
Measure Description: Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the age characteristics are the same for all three arms.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
16
  38.1%
Male
26
  61.9%
[1]
Measure Description: Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the gender characteristics are the same for all three arms.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
[1]
Measure Description: Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the regions of enrollment are the same for all three arms.
Total Enrollment Numbers   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
42
[1]
Measure Description: Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, total enrollment number is reflective of all study subjects who participated in the trial.
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.
Arm/Group Title Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: Units on Scale
Taste Score 2.7  (0.1) 2.5  (0.1) 4.2  (0.1)
Texture Score 2.4  (0.2) 2.0  (0.2) 4.3  (0.2)
Appearance Score 2.8  (0.1) 2.8  (0.1) 4.1  (0.1)
Mixability Score 2.5  (0.1) 2.1  (0.2) 4.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cholestyramine 4 Grams, Cholestyramine 12 Grams, Tang
Comments The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an “Importance of Acceptability” questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p>0.05),then it was removed from the final model.
Method measures analysis of variance
Comments Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.
2.Secondary Outcome
Title Weighted vs. Unweighted BASA Scale
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 42 42
Median (Standard Deviation)
Unit of Measure: Units on Scale
Total BASA Score 10.3  (0.4) 9.4  (0.4) 16.7  (0.5)
Weighted BASA Score 24.8  (1.3) 22.6  (1.2) 41.3  (1.8)
Time Frame Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse Event Reporting Description Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
 
Arm/Group Title Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cholestyramine 4 Grams Cholestyramine 12 Grams Tang
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/42 (4.76%)      1/42 (2.38%)      2/42 (4.76%)    
Gastrointestinal disorders       
Belching  0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0
Nausea  1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0
Loose Stool  1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0
Gas  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Urge to have bowel movement  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
(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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Harold E. Bays, MD
Organization: Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Phone: 502-515-5672
Responsible Party: Harold Bays MD, L-MARC Research Center
ClinicalTrials.gov Identifier: NCT01062269     History of Changes
Other Study ID Numbers: OO1
First Submitted: February 2, 2010
First Posted: February 4, 2010
Results First Submitted: May 18, 2010
Results First Posted: August 10, 2010
Last Update Posted: July 12, 2011