Effectiveness of Theramine on Chronic Back Pain
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|ClinicalTrials.gov Identifier: NCT01468025|
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Targeted Medical Pharma
Information provided by (Responsible Party):
Targeted Medical Pharma
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Active Theramine and Active Naproxen Other: Theramine and naproxen-like placebo Drug: Naproxen and Theramine-like placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
Primary Outcome Measures :
- Roland-Morris Lower Back Pain Scale [ Time Frame: Baseline and Day 28 ]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 [ Time Frame: Baseline and Day 28 ]Change measured in Oswestry low back pain scale.
- Visual Analog Scale [ Time Frame: Baseline and Day 28 ]Change measured in visual analog scale.
- Blood Panel [ Time Frame: Baseline and Day 28 ]Baseline and day 28 blood measurement, CBC, liver panel, CRP.
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