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A Proof-of-Concept, Randomized, Double-Blind and Placebo Controlled Clinical Trial With Naltrexone and Clonidine Combination (ATNC05) Compared With Placebo in the Treatment of Chronic Back Pain
The study includes back pain of the cervical, thoracic, and the lumbar regions.
Details
| Lead sponsor | Annette C. Toledano MD |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 78 |
| Start date | 2011-07 |
| Completion | 2013-02 |
Conditions
- Back Pain
- Lower Back Pain
- Cervical Pain
Interventions
- Naltrexone and Clonidine Combination
- placebo
Primary outcomes
- Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5) — baseline to week 3
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Countries
United States