Postherpetic NeuralgiaPhase 2NCT00809679
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
A Phase 2 study testing T-62 Dose 1 and T-62 Dose 2 in people with Postherpetic Neuralgia, run by Pfizer at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia. 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 Dose 1 and T-62 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2008to Jun 2009
- 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
- Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
- Subject is in general good health.
- Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
Who cannot join
- Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
- Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological [e.g., diabetic neuropathy], respiratory, or hepato-biliary systems [e.g., Gilbert Syndrome]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
- Subject is being treated for a medical condition that affects cardiac conduction.
- Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
- Subject has a history of asthma requiring management for reactive airway disease in the last year.
- Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia.
- Subject currently requires anticonvulsant medications to control seizures.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Albuquerque, New Mexico
Study site
Bradenton, Florida
Study site
Lexington, Kentucky
Study site
Naples, Florida
Study site
New Port Richey, Florida
Study site
Oklahoma City, Oklahoma
Study site
San Antonio, Texas
Study site
Spokane, Washington
Study site
Sunrise, Florida
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Westlake Village, California
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Read the detailed description
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
- Conditions
- Postherpetic Neuralgia
- Being tested
- T-62 Dose 1, T-62 Dose 2, Placebo
- Keywords
- Postherpetic neuralgia, Varicella Zoster, Shingles, Neuropathic pain, Analgesia, Pain
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster, Neuralgia, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-62 Dose 1Drug
Capsule dosage form 100 mg bid
T-62 Dose 2Drug
Capsule dosage form 200 mg bid
PlaceboOther
Capsule dosage form placebo bid
| Study group | Role | What they receive |
|---|---|---|
| T-62 100 mg bid | Experimental | Not described Receives: Drug: T-62 Dose 1 |
| T-62 200 mg bid | Experimental | Not described Receives: Drug: T-62 Dose 2 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores from baseline to following treatment.
Measured: weekly
Secondary outcomes (2)
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
Measured: weekly
Pharmacokinetics
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Some patients experienced asymptomatic, transient elevations in liver transaminases
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L. Rolleri, Pharm. D., Study director, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809679
- Sponsor's protocol ID
- K862-08-2002
- Status last verified
- Jun 2012
- First submitted
- 15 Dec 2008
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00809679
- Acronym / sponsor ID
- K862-08-2002
- Conditions
- Postherpetic Neuralgia
- Keywords
- Postherpetic neuralgia, Varicella Zoster, Shingles, Neuropathic pain, Analgesia, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Some patients experienced asymptomatic, transient elevations in liver transaminases
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Dec 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.
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Detailed description
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T-62 100 mg bid | Experimental | Drug: T-62 Dose 1 |
| T-62 200 mg bid | Experimental | Drug: T-62 Dose 2 |
| Placebo | Placebo comparator | Other: 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)
- Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
- Subject is in general good health.
- Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
Key exclusion criteria (7 listed)
- Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
- Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological [e.g., diabetic neuropathy], respiratory, or hepato-biliary systems [e.g., Gilbert Syndrome]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
- Subject is being treated for a medical condition that affects cardiac conduction.
- Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
- Subject has a history of asthma requiring management for reactive airway disease in the last year.
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 Dose 1Capsule dosage form 100 mg bid | Drug | T-62 100 mg bid |
| T-62 Dose 2Capsule dosage form 200 mg bid | Drug | T-62 200 mg bid |
| PlaceboCapsule dosage form placebo bid | Other | Placebo |
Primary outcome
Change in pain scores from baseline to following treatment.
Time frame: weekly
2 secondary outcomes
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
Time frame: weekly
Pharmacokinetics
Time frame: weekly
Results and safety
The study was stopped early (reason given: Some patients experienced asymptomatic, transient elevations in liver transaminases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
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)
Recruiting
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
Herpes Zoster Pain
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.
Robert L. Rolleri, Pharm. D. study director
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
13 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 Dose 1 and T-62 Dose 2 in people with Postherpetic Neuralgia, run by Pfizer at 13 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 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: stopped early, as of the sponsor's last update on 8 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 13 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. 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 was stopped early (reason given: Some patients experienced asymptomatic, transient elevations in liver transaminases). 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?
Change in pain scores from baseline to following treatment. (time frame: weekly). 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 8 Jun 2012.