NCT02701374
Completed
Phase 2
TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
Overview
- Phase
- Phase 2
- Intervention
- TRK-700
- Conditions
- Post-Herpetic Neuralgia
- Sponsor
- Toray Industries, Inc
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Change in average Numerical Rating Scale (NRS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1:TRK-700
high dose
Intervention: TRK-700
2:TRK-700
low dose
Intervention: TRK-700
3:Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Study Sites (1)
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