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COMPLETED Phase 4

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

NCT01455519 · View on ClinicalTrials.gov ↗

Study Summary

You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

Conditions Studied

Interventions

  • DRUG Sugar pill
  • DRUG Hydromorphone ER

Study Locations (1)

Illinois

  • Rehabilitation Institute of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2011-10
Est. Completion 2014-12
Phase Phase 4

Sponsor

Shirley Ryan AbilityLab

274 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01455519

The ClinicalTrials.gov registry entry for NCT01455519 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 274 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions — of which Sugar pill is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01455519 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01455519 about?

NCT01455519 is a clinical study titled "True Functional Restoration and Analgesia in Non-Radicular Low Back Pain". You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to l...

What is the current status of trial NCT01455519?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2011-10. Estimated completion is 2014-12.

What conditions does trial NCT01455519 study?

This clinical trial studies the following conditions: Low Back Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01455519?

The interventions under investigation include: Sugar pill (DRUG), Hydromorphone ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01455519?

This trial is sponsored by Shirley Ryan AbilityLab, which has 274 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01455519 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial