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NCT01455519 · ClinicalTrials.gov registry record · Phase 4
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
A Phase 4 study of Low Back Pain, sponsored by Shirley Ryan AbilityLab.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT01455519: Completed Phase 4 study of Low Back Pain, sponsored by Shirley Ryan AbilityLab.
NCT01455519 is a Phase 4 study of Low Back Pain that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 51 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01455519, a Phase 4 study of Low Back Pain, has completed, sponsored by Shirley Ryan AbilityLab.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
Conditions Studied
Interventions
- DRUG Sugar pill
- DRUG Hydromorphone ER
Study Locations (1)
Illinois
- Rehabilitation Institute of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01455519 record still lists
NCT01455519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (90% lower).
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.
NCT01455519 reports a single indexed study location in Illinois.
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.
What interventions are being tested in trial NCT01455519?
The interventions under investigation include: Sugar pill (DRUG), Hydromorphone ER (DRUG).
Who is sponsoring clinical trial NCT01455519?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01455519's enrollment target sits among peer trials
51 87th of 122 higher than 36 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain 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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