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

NCT01122108 | Completed Phase 4 Results

• 1 other identifier: 002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bile Acid Sequestrant; Resin; Lipids; Glucose; Cholesterol; Diabetes Mellitus; Bile Acid Sequestrant Acceptability Scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weighted vs. Unweighted Composite BASA Scale Scores

  1 Day

Study Arms (2)

Cholestyramine 12 grams

ACTIVE COMPARATOR

Cholestyramine 12 grams

Drug: Cholestyramine

Colesevelam HCl

ACTIVE COMPARATOR

Colesevelam HCl, 4 grams

Drug: Colesevelam HCl

Interventions

Cholestyramine DRUG

Cholestyramine 12 grams, one time dose

Also known as: Questran

Cholestyramine 12 grams

Colesevelam HCl DRUG

Colesevelam HCl, 4 grams, one time dose

Also known as: Welchol

Colesevelam HCl

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 18-70 years of age
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Louisville Metabolic and Atherosclerosis Research Center: lead
• Provident Clinical Research: collaborator
• Daiichi Sankyo: collaborator

Study Sites (1)

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Cholestyramine Resin; Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Limitations and Caveats

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

Results Point of Contact

• Title: Harold E. Bays, MD
• Organization: Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

kschmitz@lmarc.com

502-515-5672

Study Officials

• Harold E Bays, MD

  L-MARC Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 13, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 7, 2010
• Results First Posted: October 7, 2010

Record last verified: 2010-09

Locations

US (1)