Effectiveness of Theramine on Chronic Back Pain

After informed consent and screening, volunteers will be entered into a double blind, randomized, three-armed trial, with 40 patients in each group. Patients will receive either Naproxen 250 mg daily, Theramine 2 capsules two times daily, or the co-administration of low-dose Naproxen 250 mg daily with Theramine 2 capsules two times daily for 28 days.

Inclusion criteria

• 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
• 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 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 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 criteria

• Patients with back surgery in the past six 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 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 month prior to screening
• Participation in a clinical trial within the one month prior to screening
• History of epidurals in the past 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