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

Sponsors and Collaborators:	Duke University 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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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:

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
1: Experimental 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.
2: Placebo Comparator 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

Responsible Party:	Duke University Medical Center ( Wei Jiang )
Study ID Numbers:	7511-05-8, 2005-0003
Study First Received:	December 12, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00573261 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Diabetic neuropathy
Pregabalin
Lyrica

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin
Endocrine System Diseases

Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Anticonvulsants
Diabetes Complications

Additional relevant MeSH terms:

Diabetic Neuropathies
Nervous System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pharmacologic Actions
Neuromuscular Diseases

Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Diabetes Complications

ClinicalTrials.gov processed this record on July 02, 2009