A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01490905
First received: November 22, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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, Ibuprofen, and the co-administration of Ibuprofen with Theramine.


Condition Intervention Phase
Chronic Low Back Pain
Other: Theramine (A medical food)
Drug: Theraprofen
Drug: Ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • Roland-Morris Lower Back Pain Scale [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual Analog Scale Evaluation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Visual Analog Scale Evaluation.

  • Oswestry Low Back Pain Scale [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Functionality outcomes obtained from the Oswestry Low Back Pain Scale

  • C-reactive protein [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Percent change in c-reactive protein levels from baseline to Day 28.

  • Interleukin-6 [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Percent change in Il-6 level from baseline to Day 28.

  • Amino Acid Panel [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Change in amino acid turnover rate from baseline to Day 28.


Enrollment: 127
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Theramine active and ibuprofen placebo
2 capsules Theramine twice daily with one ibuprofen-like placebo once daily.
Other: Theramine (A medical food)
Theramine two capsules twice daily for 28 days.
Active Comparator: Theramine and Ibuprofen (Theraprofen)
Two capsules Theramine twice daily with Ibuprofen 400mg once daily.
Drug: Theraprofen
Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.
Active Comparator: Theramine placebo and Ibuprofen
Two Theramine-like placebo twice daily and one ibuprofen 400mg.
Drug: Ibuprofen
Ibuprofen 400mg once daily for 28 days.

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 capable of producing serious and potentially life threatening side effects. Treatments often exert a modest impact on the natural history of the condition. Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed to treat chronic back pain. NSAIDs are only moderately effective in relieving pain. NSAIDs are the leading cause of drug-induced gastrointestinal bleeds, the most common cause of drug-induced morbidity and mortality particularly at high dose. They can also exacerbate hypertension, edema and produce nephrotoxicity. The effects are also dose dependent. Recent data indicates NSAIDs are a risk factor for myocardial infarction, particularly at high doses. Recent data also indicates NSAIDs disrupt collagen repair in injured tissue. Muscle relaxants and narcotic analgesics show limited efficacy and often produce sedation, constipation or inappropriate usage. Physical therapy and local modalities often are not satisfying, costly, and require considerable investment of patient time.

Neurotransmitter depletion has been demonstrated to contribute to chronic pain states. Increased nutrient requirements associated with pain syndromes and the consequent reduced production of neurotransmitters contribute to maladaptive pain responses. The ability to enhance neurotransmitter production associated with pain syndromes is limited by multiple factors, specifically unavailability of adequate essential amino acids in the diet and increased turnover rates of amino acids needed to produce neurotransmitters in pain syndromes. Other factors such as prolonged pharmaceutical use deplete the nerve cells of neurotransmitters. Attempts to modify brain neurochemistry have focused on single neurotransmitters such as serotonin or GABA. However, this approach fails to address the complexity and complementary influences of multiple neurotransmitters on patient perception of pain and suffering.

Theramine is a proprietary prescription Medical Food which concurrently enhances several neurotransmitters that are involved in pain modulation and sensation by providing neurotransmitter precursors in the form of amino acids, (see attached Monograph for detailed discussion). Small trials have found Theramine effective in reducing and modifying pain without demonstrable side effects. Theramine simultaneously stimulates the production of the neurotransmitters serotonin, GABA, brain induced cortisol, nitric oxide, and glutamate.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  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 (3) 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 (3) 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 (6) 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 (1) 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 (1) month prior to screening
  8. Participation in a clinical trial within the one (1) month prior to screening
  9. History of epidurals in the past three (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490905

Locations
United States, California
Targeted Medical Pharma
Los Angeles, California, United States, 90077
Sponsors and Collaborators
Targeted Medical Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01490905     History of Changes
Other Study ID Numbers: 0820102
Study First Received: November 22, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Targeted Medical Pharma:
Medical food
Theramine
Ibuprofen
Amino acids
Convenience Pack Kit

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

ClinicalTrials.gov processed this record on July 26, 2014