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NCT02365636 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
A Phase 2 study of Post Herpetic Neuralgia, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT02365636: Completed Phase 2 study of Post Herpetic Neuralgia, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02365636 is a Phase 2 study of Post Herpetic Neuralgia that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 300 participants, above the 90-participant average among 4 other Post Herpetic Neuralgia trials with a reported enrollment target (233% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02365636, a Phase 2 study of Post Herpetic Neuralgia, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN
Primary Outcome
The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TV-45070
Study Locations (20)
Florida
- Teva Investigational Site 13521 - Brandon
- Teva Investigational Site 13085 - Brooksville
- Teva Investigational Site 13057 - Clearwater
- Teva Investigational Site 13084 - Fort Myers
- Teva Investigational Site 13047 - Hialeah
- Teva Investigational Site 13046 - Homestead
- Teva Investigational Site 13098 - Jacksonville
- Teva Investigational Site 13045 - Kissimmee
California
- Teva Investigational Site 13079 - Colton
- Teva Investigational Site 13331 - Pomona
- Teva Investigational Site 13341 - Sacramento
- Teva Investigational Site 13051 - Santa Monica
- Teva Investigational Site 13055 - Thousand Oaks
- Teva Investigational Site 13100 - Torrance
Alabama
- Teva Investigational Site 13052 - Birmingham
- Teva Investigational Site 13086 - Mobile
Arizona
- Teva Investigational Site 13514 - Phoenix
- Teva Investigational Site 13520 - Phoenix
Arkansas
- Teva Investigational Site 13661 - Little Rock
Connecticut
- Teva Investigational Site 13657 - Milford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2015-02-26 |
| Est. Completion | 2017-05-09 |
| Phase | Phase 2 |
What the finished NCT02365636 record still lists
NCT02365636 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 90-participant average among 4 other Post Herpetic Neuralgia trials with a reported enrollment target (233% higher).
The record links to 1 condition, with Post Herpetic Neuralgia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02365636 names 20 study sites across 6 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT02365636 about?
NCT02365636 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)". This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN
What is the current status of trial NCT02365636?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2015-02-26. Estimated completion is 2017-05-09.
What conditions does trial NCT02365636 study?
This clinical trial studies the following conditions: Post Herpetic Neuralgia.
What interventions are being tested in trial NCT02365636?
The interventions under investigation include: Placebo (DRUG), TV-45070 (DRUG).
Who is sponsoring clinical trial NCT02365636?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02365636 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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