Low Back PainPhase 3NCT01468025
Effectiveness of Theramine on Chronic Back Pain
A Phase 3 study testing Active Theramine and Active Naproxen in people with Low Back Pain, run by Targeted Medical Pharma.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Active Theramine and Active Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Active Theramine and Active Naproxen, Theramine and naproxen-like placebo, Naproxen and Theramine-like placebo
- Keywords
- NSAIDs, Theramine, naproxen, Low back pain, amino acids, CRP, Medical Food
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Theramine and Active NaproxenDrug
Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen
Theramine and naproxen-like placeboOther
Theramine, a medical food, co-administered with naproxen-like placebo
Naproxen and Theramine-like placeboDrug
naproxen co-administered with Theramine-like placebo.
| Study group | Role | What they receive |
|---|---|---|
| Theramine and naproxen | Active comparator | Patients in this group were randomly given active Theramine and active naproxen. Receives: Drug: Active Theramine and Active Naproxen |
| Theramine and placebo | Active comparator | Patients in this group were randomly given active Theramine with placebo representing naproxen. Receives: Other: Theramine and naproxen-like placebo |
| Naproxen and placebo | Active comparator | Patients in this group were randomly given active naproxen and placebo to represent Theramine. Receives: Drug: Naproxen and Theramine-like placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 28
Secondary outcomes (3)
Oswestry Low Back Pain Scale
Change measured in Oswestry low back pain scale.
Measured: Baseline and Day 28
Visual Analog Scale
Change measured in visual analog scale.
Measured: Baseline and Day 28
Blood Panel
Baseline and day 28 blood measurement, CBC, liver panel, CRP.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeted Medical Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468025
- Sponsor's protocol ID
- 0708101
- Status last verified
- Nov 2011
- First submitted
- 15 Sep 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01468025
- Acronym / sponsor ID
- 0708101
- Conditions
- Low Back Pain
- Keywords
- NSAIDs, Theramine, naproxen, Low back pain, amino acids, CRP, Medical Food
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Targeted Medical PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theramine and naproxen | Active comparator | Drug: Active Theramine and Active NaproxenPatients in this group were randomly given active Theramine and active naproxen. |
| Theramine and placebo | Active comparator | Other: Theramine and naproxen-like placeboPatients in this group were randomly given active Theramine with placebo representing naproxen. |
| Naproxen and placebo | Active comparator | Drug: Naproxen and Theramine-like placeboPatients in this group were randomly given active naproxen and placebo to represent Theramine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Theramine and Active NaproxenCo-administration of Theramine and Naproxen, CoPack Kit Theraproxen | Drug | Theramine and naproxen |
| Theramine and naproxen-like placeboTheramine, a medical food, co-administered with naproxen-like placebo | Other | Theramine and placebo |
| Naproxen and Theramine-like placebonaproxen co-administered with Theramine-like placebo. | Drug | Naproxen and placebo |
Primary outcome
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.
3 secondary outcomes
Oswestry Low Back Pain Scale
Time frame: Baseline and Day 28
Visual Analog Scale
Time frame: Baseline and Day 28
Blood Panel
Time frame: Baseline and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Theramine and Active Naproxen in people with Low Back Pain, run by Targeted Medical Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris Lower Back Pain Scale (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.