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The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.
The FAST is a questionnaire that was developed to provide a detailed assessment of flushing symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on flushing symptoms, as measured by the FAST, was also evaluated.
This study was designed to evaluate the psychometric characteristics of the FAST questionnaire.
The FAST is a self-administered questionnaire, completed using a hand-held electronic data capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each flushing event, the presence and severity of individual flushing symptoms (redness, warmth, tingling and/or itching), and an overall assessment of their flushing experience.
Evaluation of the psychometric characteristics of the FAST was based on 3 primary data analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2) construct validity based on Spearman correlation coefficients; and 3) responsiveness based on changes in FAST scores. The mean and maximum severity of flushing events, as measured by the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned above. Psychometric analyses were performed blinded to treatment group assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NER/ASA | Experimental |
| |
| NER/ASA Placebo | Experimental |
| |
| NER Placebo/ASA Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin extended-release (NER) | Drug | Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score | Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. | Week 1 to Week 2 |
| FAST Test-retest Reliability--maximum Flushing Severity Score | Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. | Week 1 to Week 2 |
| FAST Cross-sectional Construct Validity--mean Flushing Severity Score | The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome. | Week 1 |
| FAST Cross-sectional Construct Validity--maximum Flushing Severity Score | The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome. | Week 1 |
| FAST Longitudinal Construct Validity--mean Flushing Severity Score |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Severity of Flushing Events Overall During the Study | The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups. | Week 1 to Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roopal Thakkar, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19301936 | Result | Kawata AK, Revicki DA, Thakkar R, Jiang P, Krause S, Davidson MH, Punzi HA, Padley RJ. Flushing ASsessment Tool (FAST): psychometric properties of a new measure assessing flushing symptoms and clinical impact of niacin therapy. Clin Drug Investig. 2009;29(4):215-29. doi: 10.2165/00044011-200929040-00001. |
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Of the 276 subjects that were randomized, 5 discontinued from the study prior to receiving study drug due to withdrawal of consent (2), death in the family (1), positive pregnancy test (1), and lost to follow up (1).
Subjects were enrolled at 41 sites in the United States between February and June, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | NER/ASA | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily |
| FG001 | NER/ASA Placebo | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Niacin extended-release (NER) placebo | Drug | Tablets administered once daily for 6 weeks |
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| Aspirin (ASA) | Drug | Tablets (325 mg) administered once daily for 6 weeks |
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| Aspirin (ASA) placebo | Drug | Tablets administered once daily for 6 weeks |
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The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start). |
| Week 1 to Week 2 |
| FAST Longitudinal Construct Validity--maximum Flushing Severity Score | The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start). | Week 1 to Week 2 |
| FAST Responsiveness--mean Flushing Severity Score | The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened. | Study start to Day 43 |
| FAST Responsiveness--maximum Flushing Severity Score | The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened. | Study start to Day 43 |
| Anaheim |
| California |
| 92801 |
| United States |
| Walnut Creek | California | 94598 | United States |
| Denver | Colorado | 80212 | United States |
| Brooksville | Florida | 34613 | United States |
| Daytona Beach | Florida | 32127 | United States |
| Hollywood | Florida | 33023 | United States |
| Jacksonville | Florida | 32216 | United States |
| Largo | Florida | 33770 | United States |
| Miami | Florida | 33126 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Boise | Idaho | 83704 | United States |
| Chicago | Illinois | 60610 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Topeka | Kansas | 66608 | United States |
| Wichita | Kansas | 67203 | United States |
| Wichita | Kansas | 67207 | United States |
| St Louis | Missouri | 63141 | United States |
| Las Vegas | Nevada | 89146 | United States |
| Durham | North Carolina | 27704 | United States |
| High Point | North Carolina | 27262 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Portland | Oregon | 97239 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Greer | South Carolina | 29651 | United States |
| Austin | Texas | 78752 | United States |
| Carrollton | Texas | 75006 | United States |
| Dallas | Texas | 75251 | United States |
| San Antonio | Texas | 78217 | United States |
| San Antonio | Texas | 78224 | United States |
| Magna | Utah | 84044 | United States |
| Murray | Utah | 84107 | United States |
| Sandy City | Utah | 84094 | United States |
| Gig Harbor | Washington | 98335 | United States |
| Menomonee Falls | Wisconsin | 53051 | United States |
| Milwaukee | Wisconsin | 53209 | United States |
| FG002 | NER Placebo/ASA Placebo | Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NER/ASA | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily |
| BG001 | NER/ASA Placebo | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily |
| BG002 | NER Placebo/ASA Placebo | Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score | Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. | Subjects with stable flushing symptoms from Week 1 to Week 2. | Posted | Number | Intraclass correlation coefficient | Week 1 to Week 2 |
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| ||||||||||||||||||||||||||
| Secondary | Maximum Severity of Flushing Events Overall During the Study | The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups. | m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary. | Posted | Number | Percentage of subjects | Week 1 to Week 6 |
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| Primary | FAST Test-retest Reliability--maximum Flushing Severity Score | Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. | Subjects with stable flushing symptoms from Week 1 to Week 2. | Posted | Number | Intraclass correlation coefficient | Week 1 to Week 2 |
|
| |||||||||||||||||||||||||||
| Primary | FAST Cross-sectional Construct Validity--mean Flushing Severity Score | The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome. | m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary. | Posted | Number | Spearman correlation coefficient | Week 1 |
|
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| Primary | FAST Cross-sectional Construct Validity--maximum Flushing Severity Score | The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome. | m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary. | Posted | Number | Spearman correlation coefficient | Week 1 |
|
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| Primary | FAST Longitudinal Construct Validity--mean Flushing Severity Score | The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start). | m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary. | Posted | Number | Spearman correlation coefficient | Week 1 to Week 2 |
|
| |||||||||||||||||||||||||||
| Primary | FAST Longitudinal Construct Validity--maximum Flushing Severity Score | The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start). | m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary. | Posted | Number | Spearman correlation coefficient | Week 1 to Week 2 |
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| Primary | FAST Responsiveness--mean Flushing Severity Score | The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened. | Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43. | Posted | Number | Units on a scale | Study start to Day 43 |
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| Primary | FAST Responsiveness--maximum Flushing Severity Score | The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened. | Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43. | Posted | Number | Units on a scale | Study start to Day 43 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NER/ASA | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily | 1 | 74 | ||||
| EG001 | NER/ASA Placebo | Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily | 1 | 80 | ||||
| EG002 | NER Placebo/ASA Placebo | Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily | 2 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Right renal cyst | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Adenomatous polyposis | Congenital, familial and genetic disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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Provide ABBOTT at least sixty (60) days prior to submission for review, ABBOTT shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Specialist | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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