Diabetic Neuropathy, PainfulPhase 4NCT00156078
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
A Phase 4 study testing pregabalin in people with Diabetic Neuropathy, Painful, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in 20 countries.
Trial summary
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- pregabalin
- How many people
- 450 participants
- Where
- 35 sitesin 20 countries
- Study dates
- Jan 2005to May 2007
- Phase
- Phase 4
- 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
- Diagnosis of Type 1 or 2 diabetes mellitus.
- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
Who cannot join
- Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
Trial locations and contacts
35 sites in 20 countries.
35 sites in 20 countries
Turkey (Türkiye)5 sites
Pfizer Investigational Site
Ankara
Pfizer Investigational Site
Çapa, Istanbul
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Izmir
Pfizer Investigational Site
Mersin
Mexico3 sites
Pfizer Investigational Site
Mexico City
Pfizer Investigational Site
Monterrey, Nuevo León
Pfizer Investigational Site
San Luis Potosí City
Brazil2 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais
Pfizer Investigational Site
Niterói, Rio de Janeiro
Chile2 sites
Pfizer Investigational Site
Providencia, Santiago Metropolitan
Pfizer Investigational Site
Valparaíso, Valparaiso
Colombia2 sites
Pfizer Investigational Site
Bogotá, Cundinamarca
Pfizer Investigational Site
Medellín, Antioquia
Indonesia2 sites
Pfizer Investigational Site
Jakarta Pusat
Pfizer Investigational Site
Surabaya
Philippines2 sites
Pfizer Investigational Site
España, Manila
Pfizer Investigational Site
Quezon City
South Korea2 sites
Pfizer Investigational Site
Pusan
Pfizer Investigational Site
Seoul
Taiwan2 sites
Pfizer Investigational Site
Gueishan Shiang, Taoyan Hsien
Pfizer Investigational Site
Taipei
Thailand2 sites
Pfizer Investigational Site
Khet Rajathevee, Bangkok
Pfizer Investigational Site
Muang, Chiang Mai
Venezuela2 sites
Pfizer Investigational Site
Caracas, Distrito Federal
Pfizer Investigational Site
El Hatillo Municipality, Caracas-Estado Miranda
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
- Conditions
- Diabetic Neuropathy, Painful
- 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.
Mean pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 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 Neuropathy, PainfulStudies 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 4
- 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
- NCT00156078
- Sponsor's protocol ID
- A0081030
- Status last verified
- Mar 2008
- First submitted
- 7 Sep 2005
- Last updated
- 25 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
- ClinicalTrials.gov ID
- NCT00156078
- Acronym / sponsor ID
- A0081030
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 4
- 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
- Jan 2005
- Study completion
- May 2007
- First posted
- 12 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.
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
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 (2 listed)
- Diagnosis of Type 1 or 2 diabetes mellitus.
- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
Key exclusion criteria (2 listed)
- Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
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
Mean pain score
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 25 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
35 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin in people with Diabetic Neuropathy, Painful, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in 20 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 2 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 25 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 35 sites in Turkey (Türkiye), Mexico, Brazil, Chile, Colombia and 14 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean pain score. 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 NCT00156078, 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 25 Jan 2021.