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NCT02068599 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
A Phase 2 study of Osteoarthritis of the Knee, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 389
- Enrollment target
- 20
- Study locations
NCT02068599: Completed Phase 2 study of Osteoarthritis of the Knee, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02068599 is a Phase 2 study of Osteoarthritis of the Knee that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 389 participants, above the 188-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02068599, a Phase 2 study of Osteoarthritis of the Knee, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 389 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee
Primary Outcome
The Western Ontario and McMasters Universities Arthritis Index \[WOMAC\] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee. It consists of 24 items separated into 3 domains (pain \[5 items\], stiffness \[2 items\], and physical function \[17 items\]). WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. The p
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TV-45070
Study Locations (20)
Florida
- Teva Investigational Site 12256 - Clearwater
- Teva Investigational Site 12241 - DeLand
- Teva Investigational Site 12246 - Eustis
- Teva Investigational Site 12231 - Fort Myers
- Teva Investigational Site 12216 - Hialeah
- Teva Investigational Site 12230 - Jacksonville
- Teva Investigational Site 12220 - Miami
- Teva Investigational Site 12221 - Oldsmar
- Teva Investigational Site 12226 - Orlando
- Teva Investigational Site 12237 - Orlando
- Teva Investigational Site 12255 - Ormond Beach
- Teva Investigational Site 12225 - Plantation
California
- Teva Investigational Site 12217 - Anaheim
- Teva Investigational Site 12244 - Anaheim
- Teva Investigational Site 12252 - Cerritos
- Teva Investigational Site 13009 - Cerritos
- Teva Investigational Site 12233 - El Cajon
- Teva Investigational Site 12240 - Lomita
- Teva Investigational Site 12251 - Sacramento
- Teva Investigational Site 12234 - Spring Valley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2014-04-14 |
| Est. Completion | 2015-05-04 |
| Phase | Phase 2 |
What the finished NCT02068599 record still lists
NCT02068599 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, above the 188-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (107% higher).
The record links to 1 condition, with Osteoarthritis of the Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02068599 names 20 study sites across 2 states, led by Florida, California.
Frequently Asked Questions
What is clinical trial NCT02068599 about?
NCT02068599 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee". The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee
What is the current status of trial NCT02068599?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 389 participants. The study started on 2014-04-14. Estimated completion is 2015-05-04.
What conditions does trial NCT02068599 study?
This clinical trial studies the following conditions: Osteoarthritis of the Knee.
What interventions are being tested in trial NCT02068599?
The interventions under investigation include: Placebo (DRUG), TV-45070 (DRUG).
Who is sponsoring clinical trial NCT02068599?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02068599 being conducted?
This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis of the Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02068599's enrollment target sits among peer trials
389 3rd of 16 higher than 14 of 16 other Osteoarthritis of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis of the Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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