Postherpetic NeuralgiaPhase 2NCT00506610
A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
A Phase 2 study testing T-62 in people with Postherpetic Neuralgia, run by Pfizer at 8 sites in United States.
Trial summary
The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- T-62
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento 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
- Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
- Experiencing pain for at least 3 months after the healing of shingles rash
- Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
- Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
- Will not consume grapefruit or grapefruit juice during the study
Who cannot join
- Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
- Has clinically important medical disorder
- Uses certain types of medications for heart conditions
- Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
- Has a history of hypersensitivity to any medication or soy product
- Has liver or kidney disease
Show all 10Show fewer
- Has asthma that required treatment within the last year
- Has HIV or hepatitis (other than hepatitis A)
- Has a history of alcohol abuse within the past 2 years
- Has a history of (within last 2 years) or currently abuses prescription or illegal drugs
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Bradenton Research Center
Bradenton, Florida, 34205
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Plains Medical Clinic
Fargo, North Dakota, 58104
Crescent Moon Research
Murrells Inlet, South Carolina, 29576
Anchor Research Center
Naples, Florida, 34102
Suncoast Clinical Research
New Port Richey, Florida, 34652
Odyssey Research
Spokane, Washington, 99204
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.
- Conditions
- Postherpetic Neuralgia
- Being tested
- T-62
- Keywords
- Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain
- Medical subject headings
- Neuralgia, Postherpetic, Pain, Herpes Zoster, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-62Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
Measured: During each Treatment Phase Visit
Various pain related assessment
Measured: During each Treatment Phase Visit
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
Measured: At each Treatment Phase Visit
Secondary outcomes (3)
Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
Treatment-emergent changes in safety assessments
Evaluation of T-62 plasma concentrations
Measured: At various timepoints during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506610
- Sponsor's protocol ID
- K862-06-2001
- Status last verified
- Jun 2012
- First submitted
- 24 Jul 2007
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00506610
- Acronym / sponsor ID
- K862-06-2001
- Conditions
- Postherpetic Neuralgia
- Keywords
- Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 25 Jul 2007 (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 whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.
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 (5 listed)
- Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
- Experiencing pain for at least 3 months after the healing of shingles rash
- Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
- Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
- Will not consume grapefruit or grapefruit juice during the study
Key exclusion criteria (10 listed)
- Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
- Has clinically important medical disorder
- Uses certain types of medications for heart conditions
- Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
- Has a history of hypersensitivity to any medication or soy product
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 |
|---|---|---|
| T-62 | Drug | – |
Primary outcome
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
Time frame: During each Treatment Phase Visit
Various pain related assessment
Time frame: During each Treatment Phase Visit
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
Time frame: At each Treatment Phase Visit
3 secondary outcomes
Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
Treatment-emergent changes in safety assessments
Evaluation of T-62 plasma concentrations
Time frame: At various timepoints during the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
Related trials for Postherpetic Neuralgia
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Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-62 in people with Postherpetic Neuralgia, run by Pfizer at 8 sites in United States.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 withdrawn before enrolling participants, so there are no results.
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 Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) (time frame: During each Treatment Phase Visit). The study lists 3 primary outcomes in all. 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 7 Jun 2012.