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

Louisville Metabolic and Atherosclerosis Research Center

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Cholestyramine

Drug: Colesevelam HCl

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01122108

002

Details and patient eligibility

About

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.

Full 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

Enrollment

42 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.