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| Name | Class |
|---|---|
| Mark L. Wolraich | UNKNOWN |
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Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine HCL (Strattera) | Experimental | Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburg Side-Effects Scale: Motor Tics | Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation. | 12 months or study duration |
| Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Worried/Anxious | Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Dull/Tired/Listless | Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Headaches | Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Stomachaches | Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura J McGuinn, M.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Child Study Center | Oklahoma City | Oklahoma | 73117 | United States |
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Two recruits declined particicpation in this open-label study. Participants continued to take atomoxetine/placeblo (depending on prior RCT assignment) until entry into this open label study.
The study the recruited 29 (21 male/8 female) children between 10/18/2006 and 9/21/2011. The children were recruited from a prior efficacy trial. Participants for the efficacy trial were drawn from physician referral resources, self-referral, and a pool of subjects identified for a study sponsored by the Center for Disease Control and Prevention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine HCL (Strattera) | The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visits 1 (Baseline) Thru 5 |
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| Visits 5 Thru 8 |
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| Visits 8 Thru 10 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine HCL (Strattera) | The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This "titration" will occur at each visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Pittsburg Side-Effects Scale: Motor Tics | Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | Children with FAS participating in the extend safety efficacy study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
1 year
All-Ccause Mortality and Serious Adverse Events were monitored.
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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 | Atomoxetine HCL (Strattera) | The subjects received 7 days of atomoxetine at 0.5 mg/kg/day. The children were seen weekly for assessment for 4 weeks then every two weeks until the eight week double blind period was completed. After each week of treatment, response was reassessed and the dose was increased to 1.0 then 1.4 mg/kg/d unless there were excessive side effects. The subjects were then invited to continue for 1 year to assess safety and efficacy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cough |
There were a limited number of subjects because of difficulties in recruiting children with FAS and ADHD within the age group studied. We were only able to obtain a small number of teacher rating scales.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Wolraich, M.D. | University of Oklahoma Health Sciences Center | (405) 271-5700 | 45123 | mark-wolraich@ouhsc.edu |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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open label
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| 12 months or study duration |
| Pittsburg Side-Effects Scale: Crabby/Irritable | Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Socially Withdrawn | Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Hallucinations | Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Loss of Appetite | Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 12 months or study duration |
| Pittsburg Side-Effects Scale: Trouble Sleeping | Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation. | 12 months or study duration |
| 12 months or study duration |
| Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | Height measured in centimeters at the time of each visit as part of the vital signs. | 12 months or study duration |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation. | Attrition | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | 27 IN PCT and one subject did not enroll in the safety efficacy study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Worried/Anxious | Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject from RCT did not enroll in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Dull/Tired/Listless | Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject from the RCT did not enter the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Headaches | Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject from the RCT did not enter the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Stomachaches | Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject in the RCT did not enroll in the Open Label Study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Crabby/Irritable | Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One Subject in the RCT did not enroll in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
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|
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| Primary | Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject in RCT did not participate in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Socially Withdrawn | Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject in the RCT did not enroll in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Hallucinations | Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject in the RCT did not enroll in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Loss of Appetite | Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation | One subject in the RCT did not enroll in the open label study | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Primary | Pittsburg Side-Effects Scale: Trouble Sleeping | Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation. | One subject participating in the RCT did not participate in the open label | Posted | Mean | Standard Deviation | units on a scale | 12 months or study duration |
|
|
|
|
| Secondary | Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior. | ADHD Parent Rating Scale | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months or study duration |
|
|
|
|
| Secondary | Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | Height measured in centimeters at the time of each visit as part of the vital signs. | Measurements of height were not consistently obtained on all subjects. | Posted | Mean | Standard Deviation | cm | 12 months or study duration |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 19 |
| 26 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Vomiting |
|
| Headache | Nervous system disorders | Systematic Assessment | Headache |
|
| Stomachache | Gastrointestinal disorders | Systematic Assessment | Stomachache |
|
| Sleepy or Sleep Trouble | Nervous system disorders | Systematic Assessment | Sleepy or Sleep Trouble |
|
| Nasal Congestion or Rhinorrhea | General disorders | Systematic Assessment | Nasal Congestion or Rhinorrhea |
|
| Irritability | Psychiatric disorders | Systematic Assessment | Irritability |
|
| Enuresis | Renal and urinary disorders | Systematic Assessment | Enuresis |
|
| Fever | General disorders | Systematic Assessment | Fever |
|
| Upper Respiratory or Sinus Infection | Infections and infestations | Systematic Assessment | Upper Respiratory or Sinus Infection |
|
| Dizziness | General disorders | Systematic Assessment | Dizziness |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea |
|
| Ear Infection | Ear and labyrinth disorders | Systematic Assessment | Ear Infection |
|
| Skin Rash or Redness | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Rash or Redness |
|
| Sore Throat | Infections and infestations | Systematic Assessment | Sore Throat |
|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment | Decreased Appetite |
|
| Asthma or Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Asthma or Wheezing |
|
| Fatigue | General disorders | Systematic Assessment | Fatigue |
|
| Sad and Angry or Mood Swings | Psychiatric disorders | Systematic Assessment | Sad and Angry or Mood Swings |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
|
| Visit 8 |
|
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| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.24 | 2-Sided | 95 | -0.23 | 0.77 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.10 | 2-Sided | 95 | -0.17 | 0.36 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.13 | 2-Sided | 95 | -0.16 | 0.40 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
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| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -0.07 | 2-Sided | 95 | -0.36 | 0.18 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.04 | 2-Sided | 95 | -0.20 | 0.35 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -0.06 | 2-Sided | 95 | -0.49 | 0.49 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -0.01 | 2-Sided | 95 | -0.56 | 0.52 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Median Difference (Net) | -0.12 | 2-Sided | 95 | -0.64 | 0.39 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -0.09 | 2-Sided | 95 | -0.57 | 0.47 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.07 | 2-Sided | 95 | -0.21 | 0.32 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -0.22 | 2-Sided | 95 | -0.72 | 0.27 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 8 |
|
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.08 | 2-Sided | 95 | -0.19 | 0.35 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 10 |
|
|
| Superiority |
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | -2.44 | 2-Sided | 95 | -3.03 | -1.90 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |
|
| Visit 10 |
|
|
| Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the "best" fitting growth model. | Mean Difference (Net) | 0.39 | 2-Sided | 95 | -0.69 | 1.38 | This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations. | Superiority |