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A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

NCT01490905 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2011-12-13

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, Ibuprofen, and the co-administration of Ibuprofen with Theramine.

Conditions

  • Chronic Low Back Pain

Interventions

OTHER

Theramine (A medical food)

Theramine two capsules twice daily for 28 days.

DRUG

Theraprofen

Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.

DRUG

Ibuprofen

Ibuprofen 400mg once daily for 28 days.

Sponsors & Collaborators

  • Targeted Medical Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-02-28
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01490905 on ClinicalTrials.gov