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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122108
First Posted: May 13, 2010
Last Update Posted: October 7, 2010
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.
Collaborators:
Provident Clinical Research
Daiichi Sankyo, Inc.
Information provided by:
Louisville Metabolic and Atherosclerosis Research Center
  Purpose
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.

Condition Intervention Phase
Healthy Drug: Cholestyramine Drug: Colesevelam HCl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Louisville Metabolic and Atherosclerosis Research Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 Day ]
    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.


Enrollment: 42
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholestyramine 12 grams
Cholestyramine 12 grams
Drug: Cholestyramine
Cholestyramine 12 grams, one time dose
Other Name: Questran
Active Comparator: Colesevelam HCl
Colesevelam HCl, 4 grams
Drug: Colesevelam HCl
Colesevelam HCl, 4 grams, one time dose
Other Name: Welchol

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122108


Locations
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
Sponsors and Collaborators
Louisville Metabolic and Atherosclerosis Research Center
Provident Clinical Research
Daiichi Sankyo, Inc.
Investigators
Principal Investigator: Harold E Bays, MD L-MARC Research Center
  More Information

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
Last Verified: September 2010

Keywords provided by Louisville Metabolic and Atherosclerosis Research Center:
Bile Acid Sequestrant
Resin
Lipids
Glucose
Cholesterol
Diabetes Mellitus
Bile Acid Sequestrant Acceptability Scale

Additional relevant MeSH terms:
Colesevelam Hydrochloride
Cholestyramine Resin
Bile Acids and Salts
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Gastrointestinal Agents