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

A Randomized, Single-Blind, Single Research Site, Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale in Generally Healthy Subjects

The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cholestyramine; Drug: Colesevelam HCl

Detailed Description

In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women 18-70 years of age
• In general good health (defined as study participants who are medically stable, meet protocol criteria, but who may also have non-exclusionary ongoing medical conditions).
• 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
• Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.
• 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 gallbladder disease
• History of pancreatitis
• 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
• Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 days 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cholestyramine 12 grams	Drug: Cholestyramine; Cholestyramine 12 grams, one time dose; Other Names: Questran
Active Comparator: Colesevelam HCl; Colesevelam HCl, 4 grams	Drug: Colesevelam HCl; Colesevelam HCl, 4 grams, one time dose; Other Names: Welchol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weighted vs. Unweighted Composite BASA Scale Scores	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.	1 Day

Collaborators and Investigators

• Sponsor: Louisville Metabolic and Atherosclerosis Research Center
• Collaborators: Daiichi Sankyo, Inc.; Provident Clinical Research

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2010
• Last Update Submitted That Met QC Criteria: September 22, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Cholesterol; Diabetes Mellitus; Lipids; Glucose; Bile Acid Sequestrant; Resin; Bile Acid Sequestrant Acceptability Scale
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Colesevelam Hydrochloride; Cholestyramine Resin
• Other Study ID Numbers: 002 (University of CT Health Center)