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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

NCT ID: NCT01122108

Last Updated: 2010-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cholestyramine 12 grams

Cholestyramine 12 grams

Group Type ACTIVE_COMPARATOR

Cholestyramine

Intervention Type DRUG

Cholestyramine 12 grams, one time dose

Colesevelam HCl

Colesevelam HCl, 4 grams

Group Type ACTIVE_COMPARATOR

Colesevelam HCl

Intervention Type DRUG

Colesevelam HCl, 4 grams, one time dose

Interventions

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Cholestyramine

Cholestyramine 12 grams, one time dose

Intervention Type DRUG

Colesevelam HCl

Colesevelam HCl, 4 grams, one time dose

Intervention Type DRUG

Other Intervention Names

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Questran Welchol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Provident Clinical Research

OTHER

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Louisville Metabolic and Atherosclerosis Research Center

OTHER

Sponsor Role lead

Responsible Party

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L-MARC Research Center

Principal Investigators

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Harold E Bays, MD

Role: PRINCIPAL_INVESTIGATOR

L-MARC Research Center

Locations

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L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id