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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,832 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02528253
The ClinicalTrials.gov registry entry for NCT02528253 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,832 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo to Week 16; tanezumab 5mg SC is the first listed.
NCT02528253 reports 0 study locations.
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.
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