Effectiveness of Theramine on Chronic Back Pain

A Randomized Double-blind Placebo Study to Determine the Effectiveness of Theramine and a Low Dose Naproxen on the Management of Chronic Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Active Theramine and Active Naproxen; Other: Theramine and naproxen-like placebo; Drug: Naproxen and Theramine-like placebo

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
• Enrollment (Actual): 127
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Low Back Pain Scale	Change measured in Oswestry low back pain scale.	Baseline and Day 28
Visual Analog Scale	Change measured in visual analog scale.	Baseline and Day 28
Blood Panel	Baseline and day 28 blood measurement, CBC, liver panel, CRP.	Baseline and Day 28

Collaborators and Investigators

• Sponsor: Targeted Medical Pharma

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: November 5, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 5, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Low back pain; naproxen; amino acids; CRP; NSAIDs; Medical Food; Theramine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 0708101