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NCT01089725 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 385
- Enrollment target
NCT01089725: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT01089725 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 385 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01089725, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 385 participants
- Enrollment target
Study Summary
This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.
Primary Outcome
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Interventions
- BIOLOGICAL Placebo SC
- BIOLOGICAL Placebo IV
- BIOLOGICAL Tanezumab SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2010-03-30 |
| Est. Completion | 2011-02-18 |
| Phase | Phase 3 |
Why NCT01089725 stopped before completion
NCT01089725 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo SC is the first listed.
NCT01089725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01089725 about?
NCT01089725 is a clinical study titled "Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study". This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will rece...
What is the current status of trial NCT01089725?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 385 participants. The study started on 2010-03-30. Estimated completion is 2011-02-18.
What interventions are being tested in trial NCT01089725?
The interventions under investigation include: Placebo SC (BIOLOGICAL), Placebo IV (BIOLOGICAL), Tanezumab SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01089725?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01089725's enrollment target sits among peer trials
385 975th of 2000 higher than 1,026 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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