Postherpetic NeuralgiaPhase 2NCT01544296
A Comparative Study of KHK6188
A Phase 2 study testing KHK6188 in people with Postherpetic Neuralgia, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- KHK6188
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Jun 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pain for ≥ 3 months and ≤ 1 year following onset of a herpes zoster rash
- Patients with a mean pain intensity score (11-point numerical rating scale) of ≥ 4
- Patients whose rash has been healed
- Patients who are able to fill their patient diary
- Patients who provided written voluntary informed consent to participate in the study
Who cannot join
- Patients who have other pain or disease which may impair the self assessment of pain
- Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
- History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
- History or presence of a drug allergy
- Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
- Patients received an investigational medication within 4 months (6 months for biologic medication such as antibody) prior to the informed consent
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- Women of child bearing potential who do not agree to avoid pregnancy from the time of providing the consent until 3 months after the end of dosing, or men of reproductive potential who do not agree to avoid pregnancy from the time of the first dose until 3 months after the end of dosing
- Patients who are pregnant, lactating, or possibly pregnant
- Patients judged to be inappropriate to enter the study by a investigator or a subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.
- Conditions
- Postherpetic Neuralgia
- Being tested
- KHK6188, 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.
KHK6188Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KHK6188, high dose | Experimental | Not described Receives: Drug: KHK6188 |
| KHK6188, low dose | Experimental | Not described Receives: Drug: KHK6188 |
| Placebo | 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 of pain intensity score
Measured: baseline and 2weeks
Secondary outcomes (2)
Change of allodynia severity
Measured: baseline and 2 weeks
Change of global impression
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Kyowa Kirin Co., Ltd.The 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544296
- Sponsor's protocol ID
- 6188-004
- Status last verified
- Oct 2013
- First submitted
- 21 Feb 2012
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
- ClinicalTrials.gov ID
- NCT01544296
- Acronym / sponsor ID
- 6188-004
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Mar 2012 (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 placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KHK6188, high dose | Experimental | Drug: KHK6188 |
| KHK6188, low dose | Experimental | Drug: KHK6188 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pain for ≥ 3 months and ≤ 1 year following onset of a herpes zoster rash
- Patients with a mean pain intensity score (11-point numerical rating scale) of ≥ 4
- Patients whose rash has been healed
- Patients who are able to fill their patient diary
- Patients who provided written voluntary informed consent to participate in the study
Key exclusion criteria (9 listed)
- Patients who have other pain or disease which may impair the self assessment of pain
- Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
- History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
- History or presence of a drug allergy
- Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
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 |
|---|---|---|
| KHK6188 | Drug | KHK6188, high dose, KHK6188, low dose |
| Placebo | Drug | Placebo |
Primary outcome
Change of pain intensity score
Time frame: baseline and 2weeks
2 secondary outcomes
Change of allodynia severity
Time frame: baseline and 2 weeks
Change of global impression
Time frame: baseline and 2 weeks
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 10 Oct 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KHK6188 in people with Postherpetic Neuralgia, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 9 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 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 of pain intensity score (time frame: baseline and 2weeks). 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 10 Oct 2013; AzTrials last refreshed its copy on 1 Nov 2026.