Post-Herpetic NeuralgiaPhase 2NCT02701374
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia
A Phase 2 study testing TRK-700 in people with Post-Herpetic Neuralgia, run by Toray Industries, Inc at 1 site in Japan.
Trial summary
In Post-Herpetic Neuralgia(PHN) patients: To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study To measure the plasma concentration of TRK-700 and its metabolites Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Post-Herpetic Neuralgia
- What is being tested?
- TRK-700
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2016to Jul 2017
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pain persisting for at least 3 months after the onset of herpes zoster
- Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4
Who cannot join
- Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
- Patients with pain other than PHN that may affect the evaluation of pain
- Patients with pain that is suspected to be mainly psychogenic
- Patients who have received neurolytic or neurosurgical therapy for PHN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
In Post-Herpetic Neuralgia(PHN) patients:
- To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
- To measure the plasma concentration of TRK-700 and its metabolites
- Conditions
- Post-Herpetic Neuralgia
- Being tested
- TRK-700, Placebo
- Keywords
- TRK-700, Post-Herpetic Neuralgia
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-700Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1:TRK-700 | Experimental | high dose Receives: Drug: TRK-700 |
| 2:TRK-700 | Experimental | low dose Receives: Drug: TRK-700 |
| 3:Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average Numerical Rating Scale (NRS)
Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo
Measured: baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Herpetic 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701374
- Sponsor's protocol ID
- 700PNC01
- Status last verified
- Oct 2017
- First submitted
- 26 Feb 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
- ClinicalTrials.gov ID
- NCT02701374
- Acronym / sponsor ID
- 700PNC01
- Conditions
- Post-Herpetic Neuralgia
- Keywords
- TRK-700, Post-Herpetic Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 8 Mar 2016 (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.
In Post-Herpetic Neuralgia(PHN) patients:
- To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
- To measure the plasma concentration of TRK-700 and its metabolites
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1:TRK-700 | Experimental | Drug: TRK-700high dose |
| 2:TRK-700 | Experimental | Drug: TRK-700low dose |
| 3:Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pain persisting for at least 3 months after the onset of herpes zoster
- Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4
Key exclusion criteria (4 listed)
- Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
- Patients with pain other than PHN that may affect the evaluation of pain
- Patients with pain that is suspected to be mainly psychogenic
- Patients who have received neurolytic or neurosurgical therapy for PHN
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 |
|---|---|---|
| TRK-700 | Drug | 1:TRK-700, 2:TRK-700 |
| Placebo | Drug | 3:Placebo |
Primary outcome
Change in average Numerical Rating Scale (NRS)
Time frame: baseline to week 8
Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo
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 25 Oct 2017.
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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 TRK-700 in people with Post-Herpetic Neuralgia, run by Toray Industries, Inc 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 2 inclusion and 4 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 25 Oct 2017. 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 in average Numerical Rating Scale (NRS) (time frame: baseline to week 8). 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 25 Oct 2017.