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NCT02289716 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT02289716: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02289716 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02289716, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
Primary Outcome
The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
Interventions
- DRUG Placebo
- DRUG Fulranumab 1 mg
- DRUG Fulranumab 3 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-07-10 |
| Est. Completion | 2016-10-10 |
| Phase | Phase 3 |
What the finished NCT02289716 record still lists
NCT02289716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02289716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02289716 about?
NCT02289716 is a clinical study titled "Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003". The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
What is the current status of trial NCT02289716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2015-07-10. Estimated completion is 2016-10-10.
What interventions are being tested in trial NCT02289716?
The interventions under investigation include: Placebo (DRUG), Fulranumab 1 mg (DRUG), Fulranumab 3 mg (DRUG).
Who is sponsoring clinical trial NCT02289716?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02289716's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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