Status:
COMPLETED
A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
Lead Sponsor:
Targeted Medical Pharma
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
The diagnosis and management of back pain is a challenge for both primary care physicians and specialists. Establishing an etiology can be difficult and often problematic, with treatment options capab...
Eligibility Criteria
Inclusion
- Back pain lasting greater than six (6) weeks. Pain must be present on at least 5 out of 7 days during each of the two weeks prior to screening visit
- Analgesic medication used to treat pain at least 4 out of last 7 days and at least 10 days in the last month
- Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent, with diagnosis of back pain and baseline back pain greater than 40 mm out of 100 mm on visual analog scale
- Those taking an NSAID for pain must discontinue use during a washout period based on the attached five (5) half-lives of drug chart
- If undergoing physical therapy for back pain, therapy must be stable at least three (3) weeks prior to study and remain the same throughout study
- If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-convulsants-), treatment must be stable for at least three (3) months prior to study
- For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study
- Must be willing to commit to all clinical visits during study-related procedures, including required discontinuation (washout) of analgesic or anti-inflammatory medication prior to Day 1 randomization. The patient must agree to using acetaminophen for rescue medication
Exclusion
- Patients with back surgery in the past six (6) months
- Patients with significant neurologic impairment, as diagnosed on screening physical examination
- Patients with evidence or history of fracture of the spine in the past year
- Patients not fluent in English
- Use of aspirin for non-arthritic conditions, unless at a dose less than or equal to 325 mg a day, and must be stable for at least one (1) month prior to screening
- Use of controlled substances and/or opiate analgesic for pain, for more than 5 days within the last 30 days prior to screening visit
- Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening
- Participation in a clinical trial within the one (1) month prior to screening
- History of epidurals in the past three (3) months
- History of alcohol or substance abuse
- Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal or urogenital, endocrine, neurologic or psychiatric disorder
- History of gastrointestinal bleed or documented gastric or duodenal ulcer
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01490905
Start Date
September 1 2010
End Date
April 1 2011
Last Update
December 13 2011
Active Locations (1)
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1
Targeted Medical Pharma
Los Angeles, California, United States, 90077