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:
Louisville Metabolic and Atherosclerosis Research Center
Collaborators:
Provident Clinical Research
Daiichi Sankyo Inc.
Information provided by:
Louisville Metabolic and Atherosclerosis Research Center
ClinicalTrials.gov Identifier:
NCT01122108
First received: May 7, 2010
Last updated: September 22, 2010
Last verified: September 2010
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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 Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Hydrochloric acid
Cholestyramine resin
Colesevelam
Colesevelam hydrochloride
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Harold Bays, MD, L-MARC Research Center |
| ClinicalTrials.gov Identifier: | NCT01122108 History of Changes |
| Other Study ID Numbers: | 002 |
| Study First Received: | May 7, 2010 |
| Results First Received: | July 19, 2010 |
| Last Updated: | September 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Bile Acids and Salts Cholestyramine Resin Colesevelam Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013