Clinical trial NCT01468025 (phase 3, status: completed)
Conditions: low back pain
ICD codes: M54.50, M54.51, M54.59
Drugs: active theramine and active naproxen, naproxen and theramine-like placebo
SMILES: COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O, COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Back pain lasting greater than six weeks. Pain must be present on at least 5 out of 7
             days during each of the two weeks prior to screening visit

          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:

          1. Patients with back surgery in the past six months

          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