Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
127 participants
INTERVENTIONAL
2009-02-28
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Theramine and naproxen
Patients in this group were randomly given active Theramine and active naproxen.
Active Theramine and Active Naproxen
Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen
Theramine and placebo
Patients in this group were randomly given active Theramine with placebo representing naproxen.
Theramine and naproxen-like placebo
Theramine, a medical food, co-administered with naproxen-like placebo
Naproxen and placebo
Patients in this group were randomly given active naproxen and placebo to represent Theramine.
Naproxen and Theramine-like placebo
naproxen co-administered with Theramine-like placebo.
Interventions
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Active Theramine and Active Naproxen
Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen
Theramine and naproxen-like placebo
Theramine, a medical food, co-administered with naproxen-like placebo
Naproxen and Theramine-like placebo
naproxen co-administered with Theramine-like placebo.
Eligibility Criteria
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Inclusion Criteria
2. Analgesic medication used to treat pain at least 4 out of last 7 days and at least 10 days in the last month
3. 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
4. Those taking an NSAID for pain must discontinue use during a washout period based on the attached five (5) half-lives of drug chart
5. If undergoing physical therapy for back pain, therapy must be stable at least three weeks prior to study and remain the same throughout study
6. If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-convulsants-), treatment must be stable for at least three months prior to study
7. 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
8. 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 Criteria
2. Patients with significant neurologic impairment, as diagnosed on screening physical examination
3. Patients with evidence or history of fracture of the spine in the past year
4. Patients not fluent in English
5. 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 month prior to screening
6. Use of controlled substances and/or opiate analgesic for pain, for more than 5 days within the last 30 days prior to screening visit
7. Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one month prior to screening
8. Participation in a clinical trial within the one month prior to screening
9. History of epidurals in the past 3 months
10. History of alcohol or substance abuse
11. Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal or urogenital, endocrine, neurologic or psychiatric disorder
12. History of gastrointestinal bleed or documented gastric or duodenal ulcer
18 Years
75 Years
ALL
No
Sponsors
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Targeted Medical Pharma
INDUSTRY
Responsible Party
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Other Identifiers
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0708101
Identifier Type: -
Identifier Source: org_study_id