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Opioid Treatment for Chronic Low Back Pain and Mood Symptoms
NCT01502644Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2009
- Primary completion
- Jan 2013
- Countries
- 1
- Sponsor
- Brigham and Women's Hospital
- Modality
- Small Molecules
- Conditions
- chronic low back pain (CLBP)
01
Overview
Phase 4, randomised, double-blind trial of morphine and oxycodone in chronic low back pain (CLBP) (3 arms), sponsored by Brigham and Women's Hospital. Primary endpoint: Percent Change in Average Daily Pain Score at Week 20. Started Feb 2009; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Low Negative Affect
HADS score <=5 on each subscale
Moderate Negative Affect
HADS score >=6 to <=8 on each subscale
High Negative Affect
HADS score >=9 on each subscale
03
Who it enrols
Patients with chronic low back pain (>1 year) and degenerative disc disease, with no active substance abuse or history of opioid addiction. Must have normal testosterone levels (men) and not be pregnant/nursing.
04
Endpoints
Primary
Percent Change in Average Daily Pain Score
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