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NCT02528253 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,832
- Enrollment target
NCT02528253: Completed Phase 3 study, sponsored by Pfizer.
NCT02528253 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,832 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (137% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02528253, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,832 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Primary Outcome
Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Interventions
- BIOLOGICAL Placebo to Week 16; tanezumab 5mg SC
- BIOLOGICAL Placebo to Week 16, tanezumab 10 mg SC
- BIOLOGICAL Tanezumab 5 mg SC
- BIOLOGICAL Tanezumab 10 mg SC
- BIOLOGICAL Tramadol PR oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,832 participants |
| Start Date | 2015-08-18 |
| Est. Completion | 2018-12-20 |
| Phase | Phase 3 |
What the finished NCT02528253 record still lists
NCT02528253 is an interventional study that assigns participants to a tested intervention. Its 1,832 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (137% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo to Week 16; tanezumab 5mg SC is the first listed.
NCT02528253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02528253 about?
NCT02528253 is a clinical study titled "A Phase 3 Study of Tanezumab for Chronic Low Back Pain". This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of...
What is the current status of trial NCT02528253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,832 participants. The study started on 2015-08-18. Estimated completion is 2018-12-20.
What interventions are being tested in trial NCT02528253?
The interventions under investigation include: Placebo to Week 16; tanezumab 5mg SC (BIOLOGICAL), Placebo to Week 16, tanezumab 10 mg SC (BIOLOGICAL), Tanezumab 5 mg SC (BIOLOGICAL), Tanezumab 10 mg SC (BIOLOGICAL), Tramadol PR oral (BIOLOGICAL).
Who is sponsoring clinical trial NCT02528253?
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 NCT02528253's enrollment target sits among peer trials
1,832 117th of 2000 higher than 1,884 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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