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Effectiveness of Theramine on Chronic Back Pain

NCT01468025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2011-11-09

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • Targeted Medical Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-07-31
Completion
2009-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468025 on ClinicalTrials.gov