PainPhase 2NCT00159640
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
A Phase 2 study testing PD-217,014 in people with Pain, run by Pfizer at 32 sites in 7 countries.
Trial summary
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- PD-217,014
- How many people
- 315 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Feb 2004to not given
- Phase
- Phase 2
- 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
- Patients must have pain present for more than 3 months after the healing of shingles skin rash.
- Patients at screening must have a score >=40 mm on the pain visual analogue scale.
Who cannot join
- Patients with poor renal function.
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
- Patients with abnormal electrocardiogram.
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Australia7 sites
Pfizer Investigational Site
Bedford Park, South Australia
Pfizer Investigational Site
Kippa-Ring, Queensland
Pfizer Investigational Site
Maroochydore, Queensland
Pfizer Investigational Site
Perth, Western Australia
Pfizer Investigational Site
Warrawong, New South Wales
Pfizer Investigational Site
Westmead, New South Wales
Pfizer Investigational Site
Woodville
Netherlands6 sites
Pfizer Investigational Site
Arnhem
Pfizer Investigational Site
Breda
Pfizer Investigational Site
Kampen
Pfizer Investigational Site
Roosendaal
Pfizer Investigational Site
Rotterdam
Pfizer Investigational Site
Stadskanaal
Canada5 sites
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Kelowna, British Columbia
Pfizer Investigational Site
Sherbrooke, Quebec
Pfizer Investigational Site
Ste-foy, Quebec
Pfizer Investigational Site
Toronto, Ontario
Czechia5 sites
Pfizer Investigational Site
Brno
Pfizer Investigational Site
České Budějovice
Pfizer Investigational Site
CZ-Praha 8
Pfizer Investigational Site
Pilsen
Pfizer Investigational Site
Prague
Spain5 sites
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Granada, Granada
Pfizer Investigational Site
Madrid, Madrid
Pfizer Investigational Site
Málaga, MALAGA
Pfizer Investigational Site
Seville, SEVILLA
United Kingdom3 sites
Pfizer Investigational Site
London
Pfizer Investigational Site
Northampton, Northants
Pfizer Investigational Site
Portsmouth, Hants
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
- Conditions
- Pain
- Being tested
- PD-217,014
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-217,014Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.
Secondary outcomes (1)
- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)
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 startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 315 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159640
- Sponsor's protocol ID
- A4451006
- Status last verified
- Mar 2007
- First submitted
- 7 Sep 2005
- Last updated
- 28 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00159640
- Acronym / sponsor ID
- A4451006
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 315 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- 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 determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
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)
- Patients must have pain present for more than 3 months after the healing of shingles skin rash.
- Patients at screening must have a score >=40 mm on the pain visual analogue scale.
Key exclusion criteria (3 listed)
- Patients with poor renal function.
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
- Patients with abnormal electrocardiogram.
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 |
|---|---|---|
| PD-217,014 | Drug | – |
Primary outcome
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.
1 secondary outcome
- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2007.
- 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
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-217,014 in people with Pain, run by Pfizer at 32 sites in 7 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 3 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: stopped early, as of the sponsor's last update on 28 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Australia, Netherlands, Canada, Czechia, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.. 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 28 Mar 2007.