Postherpetic NeuralgiaPhase 2NCT00492323
An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).
A Phase 2 study testing carisbamate in people with Postherpetic Neuralgia and Neuralgia, run by SK Life Science, Inc..
Trial summary
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postherpetic Neuralgia, Neuralgia, Herpes Zoster
- What is being tested?
- carisbamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jun 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash
- Experienced postherpetic neuralgia pain on a daily basis for the past 3 months
- Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening.
Who cannot join
- History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch
- currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued
- past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain
- currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period
- Prior exposure to RWJ-333369 (carisbamate).
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.
Read the detailed description
Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.
- Conditions
- Postherpetic Neuralgia, Neuralgia, Herpes Zoster
- Being tested
- placebo, carisbamate
- Keywords
- pain following the healing of rashes and blisters, herpes virus, rash, varicella-zoster virus, shingles.
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia, Herpes Zoster, Blister, Exanthema, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
twice daily for 4 weeks
carisbamateDrug
200 mg tablet twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 002 | Placebo comparator | placebo twice daily for 4 weeks Receives: Drug: placebo |
| 001 | Experimental | carisbamate 200 mg tablet twice daily for 4 weeks Receives: Drug: carisbamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken.
Measured: 4 weeks
Secondary outcomes (1)
The means of the last 7 average daily PHN pain scores with no use of rescue medication, the last 7 current daily PHN pain scores, the last 7 maximum daily PHN pain scores and the last 7 daily sleep interference scores.
Measured: 4 weeks (2 four-week treatment periods (cross-over design )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionJun 2008
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.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492323
- Sponsor's protocol ID
- CR010363
- Other IDs
- 333369NPP2001
- Status last verified
- Apr 2018
- First submitted
- 25 Jun 2007
- Last updated
- 1 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.
- ClinicalTrials.gov ID
- NCT00492323
- Acronym / sponsor ID
- CR010363
- Conditions
- Postherpetic Neuralgia, Neuralgia, Herpes Zoster
- Keywords
- pain following the healing of rashes and blisters, herpes virus, rash, varicella-zoster virus, shingles.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Jun 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 evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.
Detailed description
Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 002 | Placebo comparator | Drug: placeboplacebo twice daily for 4 weeks |
| 001 | Experimental | Drug: carisbamatecarisbamate 200 mg tablet twice daily for 4 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash
- Experienced postherpetic neuralgia pain on a daily basis for the past 3 months
- Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening.
Key exclusion criteria (5 listed)
- History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch
- currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued
- past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain
- currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period
- Prior exposure to RWJ-333369 (carisbamate).
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 |
|---|---|---|
| placebotwice daily for 4 weeks | Drug | 002 |
| carisbamate200 mg tablet twice daily for 4 weeks | Drug | 001 |
Primary outcome
The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken.
Time frame: 4 weeks
1 secondary outcome
The means of the last 7 average daily PHN pain scores with no use of rescue medication, the last 7 current daily PHN pain scores, the last 7 maximum daily PHN pain scores and the last 7 daily sleep interference scores.
Time frame: 4 weeks (2 four-week treatment periods (cross-over design )
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 1 May 2018.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carisbamate in people with Postherpetic Neuralgia and Neuralgia, run by SK Life Science, Inc..
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 5 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken. (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 1 May 2018.