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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-0003 | Other Identifier | Pfizer | |
| 7511-05-8 | Other Identifier | Duke legacy protocol number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.
This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (HRV), respiratory sinus arrhythmia (RSA), minute ventilation, and changes in objective sleep parameters measured by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (EEG/EOG) by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental | Pregabalin medication |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | baseline and at end of a 4-week intervention | |
| Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram. | baseline and at end of a 4-week intervention |
| Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz). | baseline and at end of a 4-week intervention |
| Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]). | baseline and at end of a 4-week intervention |
| Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21346609 | Result | Jiang W, Ladd S, Martsberger C, Feinglos M, Spratt SE, Kuchibhatla M, Green J, Krishnan R. Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy. J Clin Psychopharmacol. 2011 Apr;31(2):207-13. doi: 10.1097/JCP.0b013e31820f4f57. |
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There were 4 subjects who provided study consent but did not complete the baseline assessment because of unwillingness to wear the LifeShirt monitor (n=2 in placebo arm) and inability of keeping baseline assessment appointment due to job reassignment (n=2 in pregabalin arm).
Subjects were recruited from the outpatient endocrine clinics of a tertiary academic center and locally via advertisement between March 3, 2006 and April 1, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
| FG001 | Pregabalin | Pregabalin medication Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin medication Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
| BG001 | Placebo |
| 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 | Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis. | Posted | Mean | Standard Deviation | mm Hg | baseline and at end of a 4-week intervention |
|
Participants were contacted by phone starting at the end of week 1 for potential adverse effects and titration of the study drug throughout 4-week treatment period.
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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 | Placebo | Placebo Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Physician defined | Non-systematic Assessment |
The study has a high dropout, which might have reduced the power of the analysis. One of the major reasons that many patients were not able to participate was an inability to commit to the relatively intense and frequent assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wei Jiang | Duke University Medical Center | 919-668-0762 | weijiang@duke.edu |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. |
|
Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN). |
| baseline and at end of a 4-week intervention |
| Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50). | baseline and at end of a 4-week intervention |
| baseline and end of 4 week intervention |
| To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety). | baseline and at end of a 4-week intervention |
| To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms) | baseline and at end of a 4-week intervention |
| To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo. | The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired). | baseline and at end of a 4-week intervention |
Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain. | A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline and end of 4 week intervention |
|
|
|
| Primary | Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram. | A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis. | Posted | Mean | Standard Deviation | Beats Per Minute | baseline and at end of a 4-week intervention |
|
|
|
| Primary | Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz). | A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis. | Posted | Mean | Standard Deviation | Hertz (Hz) | baseline and at end of a 4-week intervention |
|
|
|
| Primary | Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]). | Posted | Mean | Standard Deviation | Ratio | baseline and at end of a 4-week intervention |
|
|
|
| Primary | Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN). | A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis. | Posted | Mean | Standard Deviation | milliseconds | baseline and at end of a 4-week intervention |
|
|
|
| Primary | Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50). | Posted | Mean | Standard Deviation | Intervals more than 50 ms | baseline and at end of a 4-week intervention |
|
|
|
| Primary | Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. | Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50). | Posted | Mean | Standard Deviation | Ratio | baseline and at end of a 4-week intervention |
|
|
|
| Secondary | To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety). | Posted | Mean | Standard Deviation | units on a scale | baseline and at end of a 4-week intervention |
|
|
|
| Secondary | To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo. | The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms) | Posted | Mean | Standard Deviation | units on a scale | baseline and at end of a 4-week intervention |
|
|
|
| Secondary | To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo. | The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired). | Posted | Mean | Standard Deviation | units on a scale | baseline and at end of a 4-week intervention |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Pregabalin | Pregabalin medication Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. | 0 | 15 | 3 | 15 |
| Swelling of the lower extremities | General disorders | Physician defined | Non-systematic Assessment |
|
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Not provided
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Brief pain inventory - Most Pain |
|
| Brief pain inventory - Least Pain |
|
| Brief pain inventory - Average Pain |
|
| Brief pain inventory - Now pain |
|
| Pain interference |
|
| Affective interference |
|
| Activity Interference |
|
| Neuropathy pain scale (total) |
|
| Cold pain |
|
| Sharp pain |
|
| Deep pain |
|
| Dull pain |
|
| Hot pain |
|
| Intense pain |
|
| Itchy pain |
|
| Sensitive pain |
|
| Surface pain |
|
| Unpleasant pain |
|
| High Frequency |
|
| Normalized high frequency |
|
| SDANN |
|
| RMSSD |
|
| Disability scale - Social disability |
|
| Disability scale - Family disability |
|