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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.

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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

FieldValue
Enrollment Target 1,832 participants
Start Date 2015-08-18
Est. Completion 2018-12-20
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.