Diabetic Peripheral NeuropathyPhase 3NCT02927951
The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
A Phase 3 study testing Pregabalin in people with Diabetic Peripheral Neuropathy and Nerve Pain, run by Eastern Virginia Medical School at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Nerve Pain
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eastern Virgnia Medical School, Strelitz Diabetes Center
Norfolk, Virginia, 23510f
Strelitz Diabetes Center
Norfolk, Virginia, 23510
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy, Nerve Pain
- Being tested
- Pregabalin, Placebo
- Keywords
- Diabetes Mellitus, Peripheral Neuropathy, Diabetic Pain
- Medical subject headings
- Neuralgia, Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
150mg bid
PlaceboDrug
150mg bid
| Study group | Role | What they receive |
|---|---|---|
| pregabalin at 150 mg bid | Experimental | 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. Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment
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).
Measured: Up to 6 months
Secondary outcomes (3)
Patient-assessed change in pain intensity assessed with an 11-point scale
Based on an 11-point scale assessed after walking 50 ft in a laboratory setting.
Measured: Up to 6 months
Sleep quality assessed with the Medical Outcomes Study Sleep Scale questionnaire
assessed at home with the Medical Outcomes Study Sleep Scale questionnaire to be completed in the morning.
Measured: Up to 6 months
Patient Global Impression of Change (PGIC)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Old Dominion University
- Responsible party
- Principal investigator, Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School
- Investigators
- Aaron I Vinik, PhD, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927951
- Sponsor's protocol ID
- 10-11-FB-0209
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02927951
- Acronym / sponsor ID
- 10-11-FB-0209
- Conditions
- Diabetic Peripheral Neuropathy, Nerve Pain
- Keywords
- Diabetes Mellitus, Peripheral Neuropathy, Diabetic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Old Dominion University
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin at 150 mg bid | Experimental | Drug: PregabalinEach 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. |
| Placebo | Placebo comparator | Drug: PlaceboEach 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: Lyrica150mg bid | Drug | pregabalin at 150 mg bid |
| Placebo150mg bid | Drug | Placebo |
Primary outcome
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).
3 secondary outcomes
Patient-assessed change in pain intensity assessed with an 11-point scale
Time frame: Up to 6 months
Sleep quality assessed with the Medical Outcomes Study Sleep Scale questionnaire
Time frame: Up to 6 months
Patient Global Impression of Change (PGIC)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron I Vinik, PhD, MD principal investigator
Eastern Virginia Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Diabetic Peripheral Neuropathy and Nerve Pain, run by Eastern Virginia Medical School at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.