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

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ClinicalTrials.gov Identifier: NCT01122108
Recruitment Status : Completed
First Posted : May 13, 2010
Results First Posted : October 7, 2010
Last Update Posted : October 7, 2010
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: Colesevelam HCl
Enrollment 42
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Colesevelam HCl 3.75g First, Then Cholestyramine 12g Cholestyramine 12g First, Then Colesevelam HCl 3.75
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title Colesevelam HCl (3.75g) vs Cholestyramine (12g)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
  92.9%
>=65 years
3
   7.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
49.98  (1.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
30
  71.4%
Male
12
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colesevelam HCl (3.75g) Cholestyramine (12g)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: Units on BASA Scale
Taste Score 3.26  (.17) 2.67  (0.18)
Texture Score 2.62  (0.19) 2.36  (0.19)
Appearance Score 2.69  (0.12) 3.48  (0.15)
Mixability Score 2.74  (0.14) 2.6  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colesevelam HCl (3.75g), Cholestyramine (12g)
Comments

The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.

If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.
Method repeated measures analysis of variance
Comments Sensitivity analyses were run to evaluate possible product by sequence interactions
2.Other Pre-specified Outcome
Title Weighted vs. Unweighted Composite BASA Scale Scores
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colesevelam HCl (3.75g) Cholestyramine (12g)
Hide Arm/Group Description:
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.
[Not Specified]
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: Units on a BASA Scale
Total BASA Score 11.31  (0.40) 11.10  (0.43)
Total Weighted BASA Score 27.29  (1.21) 26.05  (1.34)
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 (12g) Colesevelam HCl (3.75 Grams) More Than 30 Minutes After Last Beverage
Hide Arm/Group Description 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. [Not Specified] 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.
All-Cause Mortality
Cholestyramine (12g) Colesevelam HCl (3.75 Grams) More Than 30 Minutes After Last Beverage
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cholestyramine (12g) Colesevelam HCl (3.75 Grams) More Than 30 Minutes After Last Beverage
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 (12g) Colesevelam HCl (3.75 Grams) More Than 30 Minutes After Last Beverage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/42 (4.76%)      3/42 (7.14%)      14/42 (33.33%)    
Gastrointestinal disorders       
Belching  0/42 (0.00%)  0 2/42 (4.76%)  2 1/42 (2.38%)  1
Burping  1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0
Mild Indigestion  1/42 (2.38%)  1 0/42 (0.00%)  0 2/42 (4.76%)  2
Mild Nausea  0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0
Abdominal Cramps  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Diarrhea  0/42 (0.00%)  0 0/42 (0.00%)  0 2/42 (4.76%)  2
Gas  0/42 (0.00%)  0 0/42 (0.00%)  0 2/42 (4.76%)  2
Moderate Indigestion  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Severe Indigestion  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Moderate Nausea  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Vomitting  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Bloating  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
General disorders       
Dry Throat  1/42 (2.38%)  1 0/42 (0.00%)  0 0/32 (0.00%)  0
Headache  1/42 (2.38%)  1 0/42 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders       
Intermittent R Back Thigh Pain  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders       
Increased Urination  0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1
Used generally healthy subjects, for who lipid-altering medication may not be indicated; Compared the BAS on the same day; Evaluated estimated equal cholesterol lowering doses of each BAS, rather than same g amt of active drug
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: NCT01122108     History of Changes
Other Study ID Numbers: 002
First Submitted: May 7, 2010
First Posted: May 13, 2010
Results First Submitted: July 19, 2010
Results First Posted: October 7, 2010
Last Update Posted: October 7, 2010