Post-Herpetic NeuralgiaPhase 4NCT00159666
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
A Phase 4 study testing pregabalin in people with Post-Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 sites in 5 countries.
Trial summary
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Herpetic Neuralgia
- What is being tested?
- pregabalin
- How many people
- 255 participants
- Where
- 40 sitesin 5 countries
- Study dates
- Oct 2004to Jun 2006
- 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 PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
- Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).
Who cannot join
- History of neurolytic or neurosurgical therapy for PHN.
- Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
United States14 sites
Pfizer Investigational Site
Allentown, Pennsylvania
Pfizer Investigational Site
Denver, Colorado
Pfizer Investigational Site
Duarte, California
Pfizer Investigational Site
Flowood, Mississippi
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Madison, Wisconsin
Pfizer Investigational Site
Oak Brook, Illinois
Pfizer Investigational Site
Palm Beach Gardens, Florida
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Seattle, Washington
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Toledo, Ohio
Germany10 sites
Pfizer Investigational Site
Berlin
Pfizer Investigational Site
Bochum
Pfizer Investigational Site
Düsseldorf
Pfizer Investigational Site
Frankfurt
Pfizer Investigational Site
Göppingen
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Hattingen
Pfizer Investigational Site
Jena
Pfizer Investigational Site
Nuremberg
Pfizer Investigational Site
Wiesbaden
Spain6 sites
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Granada
Pfizer Investigational Site
Leganés, Madrid
Pfizer Investigational Site
Salamanca
Pfizer Investigational Site
Seville
Pfizer Investigational Site
Valencia
United Kingdom6 sites
Pfizer Investigational Site
Addlestone, Surrey
Pfizer Investigational Site
Chicester, Sussex
Pfizer Investigational Site
Glasgow
Pfizer Investigational Site
Middlesbrough, Cleveland
Pfizer Investigational Site
Oldham, Lancashire
Pfizer Investigational Site
Portsmouth
Italy4 sites
Pfizer Investigational Site
L’Aquila
Pfizer Investigational Site
Perugia
Pfizer Investigational Site
Pisa
Pfizer Investigational Site
Roma
About this study
Official title: A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
- Conditions
- Post-Herpetic Neuralgia
- Being tested
- pregabalin
- Medical subject headings
- Neuralgia, Postherpetic
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.
Onset meaningful pain reduction
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 startOct 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Herpetic NeuralgiaStudies 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
- 255 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159666
- Sponsor's protocol ID
- A0081004
- Status last verified
- Nov 2006
- First submitted
- 8 Sep 2005
- Last updated
- 22 Jan 2021
- Results posted
- No
Publications
Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
PubMed 28072797Markman 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 Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo
- ClinicalTrials.gov ID
- NCT00159666
- Acronym / sponsor ID
- A0081004
- Conditions
- Post-Herpetic Neuralgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Jun 2006
- 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.
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
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 PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
- Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).
Key exclusion criteria (2 listed)
- History of neurolytic or neurosurgical therapy for PHN.
- Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
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
Onset meaningful pain reduction
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 28072797Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
- 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.
Related trials for Post-Herpetic Neuralgia
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Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
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Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
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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
40 sites in 5 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 Post-Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 sites in 5 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 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 40 sites in United States, Germany, Spain, United Kingdom, Italy. 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?
Onset meaningful pain reduction. 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 NCT00159666, which also lists 2 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.