NCT01468025

Effectiveness of Theramine on Chronic Back Pain

A Randomized Double-blind Placebo Study to Determine the Effectiveness of Theramine and a Low Dose Naproxen on the Management of Chronic Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Targeted Medical Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and tolerability of Theramine alone in patients with chronic back pain in comparison to the NSAID, Naproxen, and the co-administration of Naproxen with Theramine.

Detailed description

After informed consent and screening, volunteers will be entered into a double blind, randomized, three-armed trial, with 40 patients in each group. Patients will receive either Naproxen 250 mg daily, Theramine 2 capsules two times daily, or the co-administration of low-dose Naproxen 250 mg daily with Theramine 2 capsules two times daily for 28 days.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Active Theramine and Active Naproxen	Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen
OTHER	Theramine and naproxen-like placebo	Theramine, a medical food, co-administered with naproxen-like placebo
DRUG	Naproxen and Theramine-like placebo	naproxen co-administered with Theramine-like placebo.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2011-11-09
• Last updated: 2011-11-09