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NCT01502644 · ClinicalTrials.gov registry record · Phase 4
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT01502644: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01502644 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502644, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect \[NA\]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.
Primary Outcome
Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at ba
Interventions
- DRUG Placebo
- DRUG Oxycodone
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01502644 record still lists
NCT01502644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01502644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01502644 about?
NCT01502644 is a clinical study titled "Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms". Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect \[NA\]). The purpose of the study is to determine whether CLBP p...
What is the current status of trial NCT01502644?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2009-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01502644?
The interventions under investigation include: Placebo (DRUG), Oxycodone (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT01502644?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01502644's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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