Trial Outcomes & Findings for Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale (NCT NCT01122108)

Last Updated: 2010-10-07

Results Overview

The bile acid sequestrant acceptability (BASA) 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 for each category is 1.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

1 Day

Results posted on

2010-10-07

Participant Flow

Recruitment started in April 2010 and ended in May 2010. Enrollment officially closed on May 24th, 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 exlusion 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

Participant milestones
Measure	Colesevelam HCl 3.75g First, Then Cholestyramine 12g Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.	Cholestyramine 12g First, Then Colesevelam HCl 3.75 Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colesevelam HCl (3.75g) vs Cholestyramine (12g) n=42 Participants Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	49.98 years STANDARD_DEVIATION 1.61 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Outcome measures

Outcome measures
Measure	Colesevelam HCl (3.75g) n=42 Participants Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.	Cholestyramine (12g) n=42 Participants Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. Taste Score	3.26 Units on BASA Scale Standard Deviation .17	2.67 Units on BASA Scale Standard Deviation 0.18
Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. Texture Score	2.62 Units on BASA Scale Standard Deviation 0.19	2.36 Units on BASA Scale Standard Deviation 0.19
Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. Appearance Score	2.69 Units on BASA Scale Standard Deviation 0.12	3.48 Units on BASA Scale Standard Deviation 0.15
Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug. Mixability Score	2.74 Units on BASA Scale Standard Deviation 0.14	2.6 Units on BASA Scale Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Day

Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4.

Outcome measures

Outcome measures
Measure	Colesevelam HCl (3.75g) n=42 Participants Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.	Cholestyramine (12g) n=42 Participants Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
Weighted vs. Unweighted Composite BASA Scale Scores Total BASA Score	11.31 Units on a BASA Scale Standard Deviation 0.40	11.10 Units on a BASA Scale Standard Deviation 0.43
Weighted vs. Unweighted Composite BASA Scale Scores Total Weighted BASA Score	27.29 Units on a BASA Scale Standard Deviation 1.21	26.05 Units on a BASA Scale Standard Deviation 1.34

Adverse Events

Cholestyramine (12g)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Colesevelam HCl (3.75 Grams)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

More Than 30 Minutes After Last Beverage

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	Cholestyramine (12g) n=42 participants at risk Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.	Colesevelam HCl (3.75 Grams) n=42 participants at risk	More Than 30 Minutes After Last Beverage n=42 participants at risk This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
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.	4.8% 2/42 • Number of events 2 • 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 Burping	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.
General disorders Dry Throat	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% 0/32 • 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.
General disorders Headache	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.	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 Mild Indigestion	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.	4.8% 2/42 • Number of events 2 • 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 Mild Nausea	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 Abdominal Cramps	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 Diarrhea	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.	4.8% 2/42 • Number of events 2 • 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.	4.8% 2/42 • Number of events 2 • 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.
Renal and urinary disorders Increased Urination	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.
Musculoskeletal and connective tissue disorders Intermittent R Back Thigh Pain	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 Moderate Indigestion	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 Severe Indigestion	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 Moderate Nausea	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 Vomitting	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 Bloating	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.