Effectiveness of Theramine on Chronic Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468025
• Other study ID #: 0708101
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: November 5, 2011
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: November 2011
• Source: Targeted Medical Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Active Theramine and Active Naproxen
Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen

Other:
• Theramine and naproxen-like placebo
Theramine, a medical food, co-administered with naproxen-like placebo

Drug:
• Naproxen and Theramine-like placebo
naproxen co-administered with Theramine-like placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Oswestry Low Back Pain Scale	Change measured in Oswestry low back pain scale.	Baseline and Day 28	No
Secondary	Visual Analog Scale	Change measured in visual analog scale.	Baseline and Day 28	No
Secondary	Blood Panel	Baseline and day 28 blood measurement, CBC, liver panel, CRP.	Baseline and Day 28	Yes