NCT01415895

Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Annette C. Toledano MD · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study includes back pain of the cervical, thoracic, and the lumbar regions.

Conditions

• Back Pain
• Lower Back Pain
• Cervical Pain

Interventions

Type	Name	Description
DRUG	Naltrexone and Clonidine Combination	subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
DRUG	placebo	subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-08-12
• Last updated: 2021-04-14

Locations

1 site across 1 country: United States