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

NCT01490905 | Completed Phase 4 DMC

• 1 other identifier: 0820102
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Keywords

Medical food; Theramine; Ibuprofen; Amino acids; Convenience Pack Kit

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.

  28 Days

Secondary Outcomes (5)

• Visual Analog Scale Evaluation

  28 days

• Oswestry Low Back Pain Scale

  28 Days

• C-reactive protein

  28 Days

• Interleukin-6

  28 Days

• Amino Acid Panel

  28 Days

Study Arms (3)

Theramine active and ibuprofen placebo

ACTIVE COMPARATOR

2 capsules Theramine twice daily with one ibuprofen-like placebo once daily.

Other: Theramine (A medical food)

Theramine and Ibuprofen (Theraprofen)

ACTIVE COMPARATOR

Two capsules Theramine twice daily with Ibuprofen 400mg once daily.

Drug: Theraprofen

Theramine placebo and Ibuprofen

ACTIVE COMPARATOR

Two Theramine-like placebo twice daily and one ibuprofen 400mg.

Drug: Ibuprofen

Interventions

Theramine (A medical food) OTHER

Theramine two capsules twice daily for 28 days.

Theramine active and ibuprofen placebo

Theraprofen DRUG

Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.

Theramine and Ibuprofen (Theraprofen)

Ibuprofen DRUG

Ibuprofen 400mg once daily for 28 days.

Theramine placebo and Ibuprofen

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 (6) 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 (3) 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 (3) 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 (6) 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 (1) 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 (1) month prior to screening
• Participation in a clinical trial within the one (1) month prior to screening
• History of epidurals in the past three (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

Study Sites (1)

Targeted Medical Pharma

Los Angeles, California, 90077, United States

Location

Related Links

• Targeted Medical Pharma

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 13, 2011
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

US (1)