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Effectiveness of Theramine on Chronic Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Active Theramine and Active Naproxen

Theramine and naproxen-like placebo

Naproxen and Theramine-like placebo

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring NSAIDs, Theramine, naproxen, Low back pain, amino acids, CRP, Medical Food

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Theramine and naproxen

Theramine and placebo

Naproxen and placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oswestry Low Back Pain Scale

Change measured in Oswestry low back pain scale.

Visual Analog Scale

Change measured in visual analog scale.

Blood Panel

Baseline and day 28 blood measurement, CBC, liver panel, CRP.

Full Information

NCT ID

NCT01468025

First Posted

September 15, 2011

Last Updated

November 5, 2011

Sponsor

Targeted Medical Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01468025

Brief Title

Effectiveness of Theramine on Chronic Back Pain

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Targeted Medical Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Theramine and naproxen

Arm Type

Active Comparator

Arm Description

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

Arm Title

Theramine and placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Naproxen and placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Active Theramine and Active Naproxen

Intervention Description

Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen

Intervention Type

Other

Intervention Name(s)

Theramine and naproxen-like placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Naproxen and Theramine-like placebo

Intervention Description

naproxen co-administered with Theramine-like placebo.

Primary Outcome Measure Information:

Title

Roland-Morris Lower Back Pain Scale

Description

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.

Time Frame

Baseline and Day 28

Secondary Outcome Measure Information:

Title

Oswestry Low Back Pain Scale

Description

Change measured in Oswestry low back pain scale.

Time Frame

Baseline and Day 28

Title

Visual Analog Scale

Description

Change measured in visual analog scale.

Time Frame

Baseline and Day 28

Title

Blood Panel

Description

Baseline and day 28 blood measurement, CBC, liver panel, CRP.

Time Frame

Baseline and Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

12. IPD Sharing Statement

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Effectiveness of Theramine on Chronic Back Pain

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