RadiculopathyPhase 3NCT00159705
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
A Phase 3 study testing pregabalin in people with Radiculopathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 52 sites in 8 countries.
Trial summary
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy
- What is being tested?
- pregabalin
- How many people
- 276 participants
- Where
- 52 sitesin 8 countries
- Study dates
- Apr 2005to Jun 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
- Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
- Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.
Who cannot join
- Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
- Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
Trial locations and contacts
52 sites in 8 countries.
52 sites in 8 countries
United States13 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18013
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18017
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Independence, Missouri, 64055
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Rochester, New York, 14621
Pfizer Investigational Site
Valley Stream, New York, 11580
Canada7 sites
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Montreal, Quebec, H3A 2B4
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2E8
Germany7 sites
Pfizer Investigational Site
Bremen, 28329
Pfizer Investigational Site
Eichstätt, 85072
Pfizer Investigational Site
Göppingen, 73033
Pfizer Investigational Site
Kiel, 24105
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Nuremberg, 90489
Pfizer Investigational Site
Wiesbaden, 65189
Italy6 sites
Pfizer Investigational Site
Imperia, 18100
Pfizer Investigational Site
Localita' Cravino, Pavia, 27100
Pfizer Investigational Site
Milan, 20100
Pfizer Investigational Site
Naples, 80126
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Roma, 00168
Spain6 sites
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Granada, 18014
Pfizer Investigational Site
Madrid, 28006
Pfizer Investigational Site
Seville, 41013
Pfizer Investigational Site
Seville, 41071
Pfizer Investigational Site
Valencia, 46014
Sweden6 sites
Pfizer Investigational Site
Gothenburg, 400 10
Pfizer Investigational Site
Lidingö, 181 39
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Luleå, 972 33
Pfizer Investigational Site
Skellefteå, 931 87
Pfizer Investigational Site
Stockholm, 182 88
Belgium4 sites
Pfizer Investigational Site
Edegem, B-2650
Pfizer Investigational Site
Eeklo, B-9900
Pfizer Investigational Site
Genk, B-3600
Pfizer Investigational Site
Pellenberg, B-3212
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Inciraltı, İzmir, 35340
Pfizer Investigational Site
Istanbul, 34390
About this study
Official title: A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
- Conditions
- Radiculopathy
- Being tested
- pregabalin
- Medical subject headings
- Radiculopathy
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.
Pain measurement
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 startApr 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies 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
- 276 participants (actual)
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
- NCT00159705
- Sponsor's protocol ID
- A0081007
- Status last verified
- Oct 2008
- First submitted
- 8 Sep 2005
- Last updated
- 25 Jan 2021
- Results posted
- No
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 Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
- ClinicalTrials.gov ID
- NCT00159705
- Acronym / sponsor ID
- A0081007
- Conditions
- Radiculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jun 2007 (actual)
- 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.
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
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)
- Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
- Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.
Key exclusion criteria (2 listed)
- Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
- Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
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
Pain measurement
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.
- 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
52 sites in 8 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 Radiculopathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 52 sites in 8 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 52 sites in United States, Canada, Germany, Italy, Spain and 3 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 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?
Pain measurement. 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 25 Jan 2021.