HealthyPhase 4NCT01062269

A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study

A Phase 4 study testing Cholestyramine and Tang 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 purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the… 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 Tang
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Apr 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

Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period:
Men or women 18-70 years of age
In general good health.
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
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

Show all 15Show fewer

Current or past history of gall bladder disease
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
Blood donation within 8 weeks of the study or anticipation of blood donation during the study.
Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 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 Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects

Read the detailed description

The primary objective of this study is to evaluate patient acceptability of 2 doses of orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second objective is to assess the 2 different versions of the BASA scale. One version will be unweighted with the score based upon the aggregate score of each acceptability component. A second version will be weighted based upon subjectively-reported importance of the acceptability components. The one main study objective or focus is to determine which version of a BASA scale best differentiates patient acceptability of a bile acid sequestrant (cholestyramine) versus a placebo control powder (containing no bile acid sequestrant) thereby determining which BASA scale is the best validated instrument for future studies in assessing and comparing patient acceptability of bile acid sequestrants.

Conditions: Healthy
Being tested: Cholestyramine, Tang
Keywords: Bile acid sequestrant, Resin, Cholesterol, Diabetes mellitus, Lipids, Glucose, Bile Acid Sequestrant Acceptability Scale (BASA)validation study
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 4 grams one time dose
CholestyramineDrug
Also called Questran
Cholestyramine 12 grams one dose, one day
TangDrug
Tang one dose one day

Study groups in NCT01062269
Study group	Role	What they receive
Cholestyramine 4 grams	Active comparator	Not described Receives: Drug: Cholestyramine
Cholestyramine 12 grams	Active comparator	Not described Receives: Drug: Cholestyramine
Tang	Placebo comparator	Not described Receives: Drug: Tang

What is being measured

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

Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.
The Bile Acid Sequestrant Acceptability 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 is 1.
Measured: 1 Day

Secondary outcomes (1)

Weighted vs. Unweighted BASA Scale
The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4.
Measured: 1 Day

Timeline

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

Jan 2010Apr 2010

First posted4 Feb 2010 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionApr 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: NCT01062269
Sponsor's protocol ID: OO1
Status last verified: Jul 2011
First submitted: 2 Feb 2010
Last updated: 12 Jul 2011
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 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Single Blind Placebo Controlled Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study in Generally Healthy Subjects
ClinicalTrials.gov ID: NCT01062269
Acronym / sponsor ID: OO1
Conditions: Healthy
Keywords: Bile acid sequestrant, Resin, Cholesterol, Diabetes mellitus, Lipids, Glucose, Bile Acid Sequestrant Acceptability Scale (BASA)validation study
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: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 4 Feb 2010 (estimated)
Results: Posted 10 Aug 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: 3

Arm	Type	Receives
Cholestyramine 4 grams	Active comparator	Drug: Cholestyramine
Cholestyramine 12 grams	Active comparator	Drug: Cholestyramine
Tang	Placebo comparator	Drug: Tang

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period:
Men or women 18-70 years of age
In general good health.
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 (15 listed)

Prior intolerance to bile acid sequestrants
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

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 4 grams one time dose	Drug	Cholestyramine 4 grams
CholestyramineAlso: QuestranCholestyramine 12 grams one dose, one day	Drug	Cholestyramine 12 grams
TangTang one dose one day	Drug	Tang

Primary outcome

Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.
Time frame: 1 Day
The Bile Acid Sequestrant Acceptability 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 is 1.

1 secondary outcome

Weighted vs. Unweighted BASA Scale
Time frame: 1 Day

Results and safety

Results posted to the registry on 10 Aug 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
Cholestyramine 4 Grams vs 12 Grams vs Tang	42	42

Primary outcome: Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.

Time frame: 1 Day. Mean (Standard Deviation). Unit: Units on Scale

Measure	Cholestyramine 4 Grams n = 42	Cholestyramine 12 Grams n = 42	Tang n = 42
Taste Score	2.7 (0.1)	2.5 (0.1)	4.2 (0.1)
Texture Score	2.4 (0.2)	2.0 (0.2)	4.3 (0.2)
Appearance Score	2.8 (0.1)	2.8 (0.1)	4.1 (0.1)
Mixability Score	2.5 (0.1)	2.1 (0.2)	4.1 (0.1)

Cholestyramine 4 Grams vs Cholestyramine 12 Grams vs Tang: p <0.05, measures analysis of variance

Population analysed: Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.

1 secondary outcome is reported in the full results.

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 4 Grams	0 of 42 (0%)	2 of 42 (4.8%)	Not reported
Cholestyramine 12 Grams	0 of 42 (0%)	1 of 42 (2.4%)	Not reported
Tang	0 of 42 (0%)	2 of 42 (4.8%)	Not reported

Limitations and caveats (from the sponsor): (1)It was performed in generally healthy subjects, for whom lipid-altering medication may not be indicated.(2)The subjects' preference or dislike of the 1st or 2nd powder mixture might have influenced their ratings of the 2nd or 3rd powder.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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 Tang 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 5 inclusion and 15 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 12 Jul 2011. 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. Some participants in this study may receive a placebo. 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 10 Aug 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 Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale. (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 NCT01062269.

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 12 Jul 2011.