Diabetic NeuropathiesPhase 3NCT00143156
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3 study testing pregabalin in people with Diabetic Neuropathies, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in 2 countries.
Trial summary
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- pregabalin
- How many people
- 450 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Mar 2005to May 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 18 years of age, of any ethnic origin
- Type 1 or 2 diabetes mellitus
- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
Who cannot join
- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States53 sites
Pfizer Investigational Site
Atlanta, Georgia, 30303
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30327
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Boulder, Colorado, 80304
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Dallas, Texas, 75390-8858
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Englewood, New Jersey, 07631
Pfizer Investigational Site
Frisco, Texas, 75034
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Gatos, California, 95032-3739
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Hyde Park, New York, 11042
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Omaha, Nebraska, 68116-6465
Pfizer Investigational Site
Peoria, Illinois, 61602
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Salt Lake City, Utah, 84108
Pfizer Investigational Site
San Antonio, Texas, 78207
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Shrewsbury, New Jersey, 07702
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Springfield, Massachusetts, 01104
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tulsa, Oklahoma, 74104-5428
Pfizer Investigational Site
Tupelo, Mississippi, 38803-4087
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
West Palm Beach, Florida, 33407-2450
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
- Conditions
- Diabetic Neuropathies
- Being tested
- pregabalin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
Secondary outcomes (1)
End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143156
- Sponsor's protocol ID
- A0081071
- Status last verified
- Apr 2008
- First submitted
- 31 Aug 2005
- Last updated
- 22 Jan 2021
- Results posted
- No
Publications
Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
PubMed 31802967Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
PubMed 30521533Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
PubMed 30206821Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
PubMed 30084288Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
PubMed 27611736
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00143156
- Acronym / sponsor ID
- A0081071
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2007 (actual)
- First posted
- 2 Sep 2005 (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.
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females at least 18 years of age, of any ethnic origin
- Type 1 or 2 diabetes mellitus
- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
Key exclusion criteria (2 listed)
- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
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 |
|---|---|---|
| pregabalin | Drug | – |
Primary outcome
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
1 secondary outcome
End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.
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 22 Jan 2021.
- Derived from this study: PubMed 31802967Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
- Derived from this study: PubMed 30521533Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
- Derived from this study: PubMed 30206821Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
- Derived from this study: PubMed 30084288Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
- Derived from this study: PubMed 27611736Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 2 countries: 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 Neuropathies, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in 2 countries.
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 3 inclusion and 2 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Puerto Rico. 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. 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?
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143156, which also lists 5 linked publications.
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 22 Jan 2021.