A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathy |
Drug: Pregabalin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Single Center Study Designed to Assess the Effects of Pregabalin on Change in Patients With Diabetic Neuropathy |
- Assessing the change of parameters of autonomic nerve function such as Heart Rate Variability (HRV), Respiratory Sinus Arrhythmia (RSA), minute ventilation, and blood pressure by means of the LifeShirt [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
- Assessing the change of pain symptoms upon treatment of pregabalin in comparison to placebo [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Pregabalin medication
|
Drug: 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.
Other Name: Lyrica
|
|
Placebo Comparator: 2
Placebo
|
Drug: 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.
|
Detailed Description:
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 HRV, 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Outpatients aged 18 years or older
- Meet criteria for diagnosis of diabetic neuropathy
- Average daily pain scores greater than or equal to 4 by Visual Analog Scale
- Ability to give informed consent
- No pregnancy
Exclusion Criteria:
- Patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, PTSD, OCD, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts
- Patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. These patients must take the last dose of gabapentin the night before starting the study.
- Patients being non-compliant with diabetic control
- Inability to wear the LifeShirt
- Unable to participate or answer questions using a PDA input device
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Wei Jiang, M.D. | Duke University |
More Information
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wei Jiang, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00573261 History of Changes |
| Other Study ID Numbers: | 7511-05-8, 2005-0003 |
| Study First Received: | December 12, 2007 |
| Last Updated: | November 6, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Diabetic neuropathy Pregabalin Lyrica |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 22, 2013