A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy
Information source: Duke University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Neuropathy
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Wei Jiang, M.D., Principal Investigator, Affiliation: Duke University
Overall contact:
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: 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
Secondary outcome: Assessing the change of pain symptoms upon treatment of pregabalin in comparison to placebo
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Wei Jiang, M.D., Principal Investigator
Additional Information
Starting date: March 2006
Ending date: May 2008
Last updated: December 14, 2007
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