Neuralgia, PostherpeticPhase 2NCT00614705
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
A Phase 2 study testing PH-797804 in people with Neuralgia, Postherpetic, run by Pfizer at 25 sites in 6 countries.
Trial summary
This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- PH-797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Apr 2008to Dec 2008
- 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
- Male or female, at least 18 years of age
- Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
- Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).
Who cannot join
- Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
- History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
- Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
- A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
- Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
- ECG abnormalities at screening or randomization
- Evidence of organ dysfunction or hematopoietic disorder
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Ukraine8 sites
Pfizer Investigational Site
Dnipropetrovsk, 49616
Pfizer Investigational Site
Donetsk, 83045
Pfizer Investigational Site
Kharkiv, 61052
Pfizer Investigational Site
Kharkiv, 61068
Pfizer Investigational Site
Kharkiv, 61178
Pfizer Investigational Site
Kyiv, 04050
Pfizer Investigational Site
Odesa, 65025
Pfizer Investigational Site
Simferopol, 95006
Spain5 sites
Pfizer Investigational Site
Cadiz, Cadiz, 11009
Pfizer Investigational Site
Madrid, Madrid, 28006
Pfizer Investigational Site
Ourense, Ourense, 32005
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valencia, Valencia, 46014
Russia4 sites
Pfizer Investigational Site
Moscow, 123098
Pfizer Investigational Site
Saint Petersburg, 194175
Pfizer Investigational Site
Saint Petersburg, 194354
Pfizer Investigational Site
Yaroslavl, 150030
United Kingdom4 sites
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ
Pfizer Investigational Site
Blackpool, Lancashire, FY3 7EN
Pfizer Investigational Site
Solihull, B91 2JL
Pfizer Investigational Site
Weybridge, Surrey, KT15 2BH
Sweden3 sites
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Stockholm, 114 54
Pfizer Investigational Site
Stockholm, 115 22
About this study
Official title: A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia
This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.
- Conditions
- Neuralgia, Postherpetic
- Being tested
- PH-797804, Placebo
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-797804Drug
6 mg dose in oral capsule form, once daily for 28 days
PlaceboDrug
oral capsule form, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PH-797804 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
Measured: 4 weeks
Secondary outcomes (3)
PH-797804 pharmacokinetics
Measured: Weeks 1, 2, and 4
Patient global impression of change
Measured: Week 4
Neuropathic Pain Symptom Inventory
Measured: Baseline and Weeks 1, 2, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia, PostherpeticStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
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
- NCT00614705
- Sponsor's protocol ID
- A6631013
- Status last verified
- May 2011
- First submitted
- 31 Jan 2008
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00614705
- Acronym / sponsor ID
- A6631013
- Conditions
- Neuralgia, Postherpetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Feb 2008 (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.
This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PH-797804 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, at least 18 years of age
- Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
- Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).
Key exclusion criteria (7 listed)
- Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
- History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
- Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
- A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
- Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
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 |
|---|---|---|
| PH-7978046 mg dose in oral capsule form, once daily for 28 days | Drug | 1 |
| Placebooral capsule form, once daily for 28 days | Drug | 2 |
Primary outcome
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
Time frame: 4 weeks
3 secondary outcomes
PH-797804 pharmacokinetics
Time frame: Weeks 1, 2, and 4
Patient global impression of change
Time frame: Week 4
Neuropathic Pain Symptom Inventory
Time frame: Baseline and Weeks 1, 2, and 4
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 16 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Neuralgia, Postherpetic
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Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
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
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH-797804 in people with Neuralgia, Postherpetic, run by Pfizer at 25 sites in 6 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 7 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Ukraine, Spain, Russia, United Kingdom, Sweden 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. Some participants in this study may receive a placebo. 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 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?
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale (time frame: 4 weeks). 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 16 May 2011.