Effectiveness of Theramine on Chronic Back Pain

NCT01468025 | Completed Phase 3

• 1 other identifier: 0708101
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

NSAIDs; Theramine; naproxen; Low back pain; amino acids; CRP; Medical Food

Outcome Measures

Primary Outcomes (1)

• Roland-Morris Lower Back Pain Scale

  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.

  Baseline and Day 28

Secondary Outcomes (3)

• Oswestry Low Back Pain Scale

  Baseline and Day 28

• Visual Analog Scale

  Baseline and Day 28

• Blood Panel

  Baseline and Day 28

Study Arms (3)

Theramine and naproxen

ACTIVE COMPARATOR

Patients in this group were randomly given active Theramine and active naproxen.

Drug: Active Theramine and Active Naproxen

Theramine and placebo

ACTIVE COMPARATOR

Patients in this group were randomly given active Theramine with placebo representing naproxen.

Other: Theramine and naproxen-like placebo

Naproxen and placebo

ACTIVE COMPARATOR

Patients in this group were randomly given active naproxen and placebo to represent Theramine.

Drug: Naproxen and Theramine-like placebo

Interventions

Active Theramine and Active Naproxen DRUG

Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen

Theramine and naproxen

Theramine and naproxen-like placebo OTHER

Theramine, a medical food, co-administered with naproxen-like placebo

Theramine and placebo

Naproxen and Theramine-like placebo DRUG

naproxen co-administered with Theramine-like placebo.

Naproxen and placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Targeted Medical Pharma: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: November 9, 2011
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 9, 2011

Record last verified: 2011-11