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Trial record 74 of 424 for:    Pregabalin

The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT02927951
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
Old Dominion University
Information provided by (Responsible Party):
Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School

Brief Summary:
The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Nerve Pain Drug: Pregabalin Drug: Placebo Phase 3

Detailed Description:

Pregabalin (LYRICA®) is a potent and specific ligand at the alpha-2-delta subunit of voltage-gated calcium channels. It is currently approved for adjunctive therapy for neuropathic pain conditions. Patients with diabetic peripheral neuropathy suffer from pain in their feet which interferes with their ability to walk which includes less walking, an altered gait, and altered balance. At night the peripheral neuropathy also interferes with their sleep patterns.The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.Pain and sleep quality will be assessed with questionnaires but objective measurements will be used to assess gait, balance, daytime activities (including walking) and sleep patterns.

Statistical Power Calculations were based on the fact that this is a randomized, double-blind, placebo-controlled, 2-period crossover study to be conducted at a single site. Comparisons will be drawn at baseline, at the completion of each 6 weeks of treatment/placebo arm. The study has been powered at 0.80 for a two-tail analysis with a sensitivity to detect a 30% delta in pain perception in 40 subjects. From previous studies, the cross-over design suggested has achieved significance with 20 patients per group. Forty-four patients will be recruited in total. Significance will be established at an alpha level of 0.05. Both parametric and non parametric correlations will be carried out between the different variables measured and progressive logistic regression to determine the relative contributions of pain relief on the primary and secondary variables being measured in the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Cross-over Study on the Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: pregabalin at 150 mg bid
Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.
Drug: Pregabalin
150mg bid
Other Name: Lyrica

Placebo Comparator: Placebo
Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.
Drug: Placebo
150mg bid




Primary Outcome Measures :
  1. Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment [ Time Frame: Up to 6 months ]
    The falls risk will also be ascertained using the long-form Physiological Profile Assessment. The Physiological Profile Assessment has been validated in prospective studies of falls in both community and institutional settings, and predicts those at increased risk of falling with 75-79% accuracy. The Physiological Profile Assessment includes tests of vision (edge contrast sensitivity, high/low contrast visual acuity, depth perception), sensation (ankle touch sensitivity, leg proprioception), leg muscle strength (knee flexion, knee extensors, ankle dorsiflexion), postural sway and postural coordination. Scores from each of these physiologic tests are combined to provide an overall fall risk score that ranges from -2 (very low risk) to +4 (very marked risk).


Secondary Outcome Measures :
  1. Patient-assessed change in pain intensity assessed with an 11-point scale [ Time Frame: Up to 6 months ]
    Based on an 11-point scale assessed after walking 50 ft in a laboratory setting.

  2. Sleep quality assessed with the Medical Outcomes Study Sleep Scale questionnaire [ Time Frame: Up to 6 months ]
    assessed at home with the Medical Outcomes Study Sleep Scale questionnaire to be completed in the morning.

  3. Patient Global Impression of Change (PGIC) [ Time Frame: Up to 6 months ]
    Patients will record pain and sleep information in diaries. The Patient Global Impression of Change is a 7-point scale on which patients will rate any change in their overall status that they had experienced since beginning study medication from much improved to much worse. The Patient Global Impression of Change is also a 7-point scale on which the clinician rated the change observed in the patient's overall status since the beginning of the study.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).

Exclusion Criteria:

  • Active ocular or systemic disease
  • Recent or recurrent history of musculoskeletal injury,
  • Presence of neurological conditions or idiopathic neuropathy
  • History of or vertigo
  • Use of an aid while walking or difficulty with standing upright
  • Visible tremor or uncorrected visual deficits.
  • Presence of type 1 diabetes mellitus (defined as C-peptide < 1 ng/ml or diabetes onset at < 35 years of age in a non-obese patient).
  • Presence of diabetic retinopathy that is more severe than "background" level.
  • Presence of diabetic nephropathy
  • Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
  • Bilateral amputation of lower extremities or foot ulcers involving the great toes.
  • Presence of neuroarthropathy (Charcot deformity) is allowable.
  • History of major macrovascular events such as myocardial infarction or stroke within the past 6 months.
  • Patients with moderate or severe hepatic insufficiency or abnormalities of liver function.
  • Presence of significant pedal edema.
  • Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927951


Locations
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United States, Virginia
Eastern Virgnia Medical School, Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510f
Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Eastern Virginia Medical School
Old Dominion University
Investigators
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Principal Investigator: Aaron I Vinik, PhD, MD Eastern Virginia Medical School

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Responsible Party: Aaron I. Vinik, MD, PhD, Director of Research & Neuroendocrine Unit, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT02927951     History of Changes
Other Study ID Numbers: 10-11-FB-0209
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School:
Diabetes Mellitus
Peripheral Neuropathy
Diabetic Pain

Additional relevant MeSH terms:
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Pregabalin
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuralgia
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs