HealthyPhase 4NCT01122108

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

A Phase 4 study testing Cholestyramine and Colesevelam HCl in people with Healthy, run by Louisville Metabolic and Atherosclerosis Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Cholestyramine and Colesevelam HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Jun 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

L-MARC Research Center
Louisville, Kentucky, 40213

Other trials in United States

About this study

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

Read the 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

Conditions: Healthy
Being tested: Cholestyramine, Colesevelam HCl
Keywords: Bile Acid Sequestrant, Resin, Lipids, Glucose, Cholesterol, Diabetes Mellitus, Bile Acid Sequestrant Acceptability Scale
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CholestyramineDrug
Also called Questran
Cholestyramine 12 grams, one time dose
Colesevelam HClDrug
Also called Welchol
Colesevelam HCl, 4 grams, one time dose

Study groups in NCT01122108
Study group	Role	What they receive
Cholestyramine 12 grams	Active comparator	Cholestyramine 12 grams Receives: Drug: Cholestyramine
Colesevelam HCl	Active comparator	Colesevelam HCl, 4 grams Receives: Drug: Colesevelam HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2010

First posted13 May 2010 (estimated)
Study startApr 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01122108
Sponsor's protocol ID: 002
Status last verified: Sep 2010
First submitted: 7 May 2010
Last updated: 7 Oct 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01122108
Acronym / sponsor ID: 002
Conditions: Healthy
Keywords: Bile Acid Sequestrant, Resin, Lipids, Glucose, Cholesterol, Diabetes Mellitus, Bile Acid Sequestrant Acceptability Scale
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Louisville Metabolic and Atherosclerosis Research CenterUniversity, hospital or other
Collaborators: Provident Clinical Research, Daiichi Sankyo
Study start: Apr 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 13 May 2010 (estimated)
Results: Posted 7 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Cholestyramine 12 grams	Active comparator	Drug: CholestyramineCholestyramine 12 grams
Colesevelam HCl	Active comparator	Drug: Colesevelam HClColesevelam HCl, 4 grams

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CholestyramineAlso: QuestranCholestyramine 12 grams, one time dose	Drug	Cholestyramine 12 grams
Colesevelam HClAlso: WelcholColesevelam HCl, 4 grams, one time dose	Drug	Colesevelam HCl

Primary outcome

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.

Results and safety

Results posted to the registry on 7 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colesevelam HCl 3.75g First, Then Cholestyramine 12g	21	21
Cholestyramine 12g First, Then Colesevelam HCl 3.75	21	21

Primary outcome: 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. Mean (Standard Deviation). Unit: Units on BASA Scale

Measure	Colesevelam HCl (3.75g) n = 42	Cholestyramine (12g) n = 42
Taste Score	3.26 (.17)	2.67 (0.18)
Texture Score	2.62 (0.19)	2.36 (0.19)
Appearance Score	2.69 (0.12)	3.48 (0.15)
Mixability Score	2.74 (0.14)	2.6 (0.14)

Colesevelam HCl (3.75g) vs Cholestyramine (12g): p <0.05, repeated measures analysis of variance

Adverse events

Time frame: Adverse events were collected from the time the subject signed the informed consent to up to 7 days after the study visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cholestyramine (12g)	0 of 42 (0%)	2 of 42 (4.8%)	Not reported
Colesevelam HCl (3.75 Grams)	0 of 42 (0%)	3 of 42 (7.1%)	Not reported
More Than 30 Minutes After Last Beverage	0 of 42 (0%)	14 of 42 (33.3%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harold E Bays, MD principal investigator

L-MARC Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cholestyramine and Colesevelam HCl in people with Healthy, run by Louisville Metabolic and Atherosclerosis Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01122108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2010.