Trial Outcomes & Findings for A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study (NCT NCT01062269)
NCT ID: NCT01062269
Last Updated: 2011-07-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
1 Day
Results posted on
2011-07-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Cholestyramine 4 Grams vs 12 Grams vs Tang
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 Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
Baseline characteristics by cohort
| Measure |
Cholestyramine 4 Grams vs 12 Grams vs Tang
n=42 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
51.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
|
Total Enrollment Numbers
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.
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.
Outcome measures
| Measure |
Cholestyramine 4 Grams
n=42 Participants
|
Cholestyramine 12 Grams
n=42 Participants
|
Tang
n=42 Participants
|
|---|---|---|---|
|
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.
Mixability Score
|
2.5 Units on Scale
Standard Deviation 0.1
|
2.1 Units on Scale
Standard Deviation 0.2
|
4.1 Units on Scale
Standard Deviation 0.1
|
|
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.
Taste Score
|
2.7 Units on Scale
Standard Deviation 0.1
|
2.5 Units on Scale
Standard Deviation 0.1
|
4.2 Units on Scale
Standard Deviation 0.1
|
|
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.
Texture Score
|
2.4 Units on Scale
Standard Deviation 0.2
|
2.0 Units on Scale
Standard Deviation 0.2
|
4.3 Units on Scale
Standard Deviation 0.2
|
|
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.
Appearance Score
|
2.8 Units on Scale
Standard Deviation 0.1
|
2.8 Units on Scale
Standard Deviation 0.1
|
4.1 Units on Scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 1 DayThe 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.
Outcome measures
| Measure |
Cholestyramine 4 Grams
n=42 Participants
|
Cholestyramine 12 Grams
n=42 Participants
|
Tang
n=42 Participants
|
|---|---|---|---|
|
Weighted vs. Unweighted BASA Scale
Total BASA Score
|
10.3 Units on Scale
Standard Deviation 0.4
|
9.4 Units on Scale
Standard Deviation 0.4
|
16.7 Units on Scale
Standard Deviation 0.5
|
|
Weighted vs. Unweighted BASA Scale
Weighted BASA Score
|
24.8 Units on Scale
Standard Deviation 1.3
|
22.6 Units on Scale
Standard Deviation 1.2
|
41.3 Units on Scale
Standard Deviation 1.8
|
Adverse Events
Cholestyramine 4 Grams
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cholestyramine 12 Grams
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tang
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cholestyramine 4 Grams
n=42 participants at risk
|
Cholestyramine 12 Grams
n=42 participants at risk
|
Tang
n=42 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Belching
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
|
Gastrointestinal disorders
Loose Stool
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
|
Gastrointestinal disorders
Urge to have bowel movement
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
0.00%
0/42 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.
Adverse events were assessed in clinic during the study visit and through a follow-up phone call 1-7 days after the study visit.
|
Additional Information
Harold E. Bays, MD
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Phone: 502-515-5672
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place