A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy - Full Text View

Sponsor:	Duke University
Collaborator:	Pfizer
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00573261

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 IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573261

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Pfizer

Investigators

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):

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.

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 February 12, 2012