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Placebo effect
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Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.
The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.
One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for ~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline | Experimental | Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
|
| Placebo | Placebo Comparator | Patients will take placebo 3 times per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect. | 12 weeks |
| Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score) | 12 Weeks |
| Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaldo E Rivera, M.D. | University of Missouri - Department of Otolaryngology - Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pentoxifylline | Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
| FG001 | Placebo | Placebo: Patients will take placebo 3 times per day for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We only evaluated patients that completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Pentoxifylline | Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
| BG001 | Placebo | Placebo: Patients will take placebo 3 times per day for 12 weeks |
| 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 | Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect. | Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the Dizziness Handicap Inventory | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks |
|
12 weeks
Definition of adverse event and/or serious adverse event is not different than that published on clinicaltrials.gov.
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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 | Pentoxifylline | Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
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Early termination due to placebo effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Director of Research | University of Missouri | 573-882-2549 | schneiderri@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2015 | Jun 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Placebo | Drug | Patients will take placebo 3 times per day for 12 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pentoxifylline |
Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks |
| OG001 | Placebo | Placebo: Patients will take placebo 3 times per day for 12 weeks |
|
|
| Primary | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score) | Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the European Evaluation of Vertigo scale | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
|
|
| Primary | Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem. | Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on Vestibular Activities and participation survey | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | Placebo: Patients will take placebo 3 times per day for 12 weeks | 0 | 13 | 0 | 13 | 0 | 13 |
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| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Baseline EEV - Duration of Illusion |
|
| EOT EEV - Duration of Illusion |
|
| Baseline EEV - Motion Intolerance |
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| End of Treatment EEV - Motion Intolerance |
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| Baseline EEV - Neurovegetative |
|
| End of Treatment EEV - Neurovegetative |
|
| Baseline EEV - Instability |
|
| EOT - Instability |
|