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

NCT00573261 | Completed Phase 4 Results

• 3 other identifiers: Pro000095572005-00037511-05-8
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathy

Keywords

Diabetic neuropathy; Pregabalin; Lyrica

Outcome Measures

Primary Outcomes (6)

• Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.

  baseline and at end of a 4-week intervention

• 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.

  The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.

  baseline and at end of a 4-week intervention

• 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.

  Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).

  baseline and at end of a 4-week intervention

• 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.

  Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/\[total power-VLF\]) and normalized HF (normalized HF=HF/\[total power-VLF\]).

  baseline and at end of a 4-week intervention

• 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.

  Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).

  baseline and at end of a 4-week intervention

• 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.

  Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).

  baseline and at end of a 4-week intervention

Secondary Outcomes (4)

• To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.

  baseline and end of 4 week intervention

• To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.

  baseline and at end of a 4-week intervention

• To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.

  baseline and at end of a 4-week intervention

• To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.

  baseline and at end of a 4-week intervention

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin medication

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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. doi: 10.1097/JCP.0b013e31820f4f57.

  PMID: 21346609 RESULT

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study has a high dropout, which might have reduced the power of the analysis. One of the major reasons that many patients were not able to participate was an inability to commit to the relatively intense and frequent assessments.

Results Point of Contact

• Title: Dr. Wei Jiang
• Organization: Duke University Medical Center

weijiang@duke.edu

919-668-0762

Study Officials

• Wei Jiang, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 21, 2014
• Results First Posted: July 18, 2013

Record last verified: 2013-07

Locations

US (1)