Effectiveness of Theramine on Chronic Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468025
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Information provided by (Responsible Party):
Targeted Medical Pharma

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 alone in patients with chronic back pain in comparison to the NSAID, Naproxen, and the co-administration of Naproxen with Theramine.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Active Theramine and Active Naproxen Other: Theramine and naproxen-like placebo Drug: Naproxen and Theramine-like placebo Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Placebo Study to Determine the Effectiveness of Theramine and a Low Dose Naproxen on the Management of Chronic Back Pain
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Theramine and naproxen
Patients in this group were randomly given active Theramine and active naproxen.
Drug: Active Theramine and Active Naproxen
Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen

Active Comparator: Theramine and placebo
Patients in this group were randomly given active Theramine with placebo representing naproxen.
Other: Theramine and naproxen-like placebo
Theramine, a medical food, co-administered with naproxen-like placebo

Active Comparator: Naproxen and placebo
Patients in this group were randomly given active naproxen and placebo to represent Theramine.
Drug: Naproxen and Theramine-like placebo
naproxen co-administered with Theramine-like placebo.

Primary Outcome Measures :
  1. Roland-Morris Lower Back Pain Scale [ Time Frame: Baseline and Day 28 ]
    The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Roland-Morris Lower Back Pain Scale.

Secondary Outcome Measures :
  1. Oswestry Low Back Pain Scale [ Time Frame: Baseline and Day 28 ]
    Change measured in Oswestry low back pain scale.

  2. Visual Analog Scale [ Time Frame: Baseline and Day 28 ]
    Change measured in visual analog scale.

  3. Blood Panel [ Time Frame: Baseline and Day 28 ]
    Baseline and day 28 blood measurement, CBC, liver panel, CRP.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Targeted Medical Pharma Identifier: NCT01468025     History of Changes
Other Study ID Numbers: 0708101
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Targeted Medical Pharma:
Low back pain
amino acids
Medical Food

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action