Phase 4 N=40 Randomized Quadruple-blind Treatment

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

Diabetic Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT00573261 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy. — -7.63; -8.98; -4.41; -4.93 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.	-7.63; -8.98; -4.41; -4.93	—
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.	-2.94; -3.49	—
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.	0.37; -1.30; 0.0066; -0.049; -0.038; 0.039	—
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.	0.37; -1.30; 0.0066; -0.049; -0.038; 0.039	—
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.	0.011; 0.0015	—
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.	0.011; 0.0015	—
SECONDARY To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.	-21.29; -43.27; -1.36; -9.13; -1.07; -3.33	—
SECONDARY To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.	0.57; 1.2; 1; -3.67	—
SECONDARY To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.	1.21; -1.20	—
SECONDARY To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.	-1.67; -7.73; -0.42; -2.93; -0.58; -2.13	—

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.

Eligibility 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, obsessive compulsive disorder, 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 personal digital assistant input device

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00573261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.