Low Back PainNCT01990729
Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain
An observational study of Low Back Pain, run by Unipharm, Inc. at 1 site in Russia.
Trial summary
To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- ARTRA
- How many people
- 10,000 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2010to Jan 2013
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic low back pain in ambulatory care
Who may be able to join
- Patients aged 40-65 years, inclusively.
- Pain intensity according to Visual Analogue Scale (VAS) > 3 points.
- Duration of back pain > 12 weeks.
- Pain reinforcement during movement in lumbar spine.
- Osteoarthritis, spondylarthrosis, osteochondrosis.
- Given written Informed consent form for participation in the study.
- Treatment with ARTRA
Who cannot join
- History of allergic reactions to chondroprotectors.
- Participation in another clinical study within 30 days before screening or during this study.
- Fibromyalgia.
- Active neoplastic disease, history of neoplastic disease within 3 years before screening.
- Paget's disease.
- Degenerative spondylolisthesis.
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- Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening.
- History of alcohol or drug abuse.
- Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache.
- History of any disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject during participation in the study
- Clinically significant renal disorders.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care
To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.
Read the detailed description
We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.
- Conditions
- Low Back Pain
- Being tested
- ARTRA
- 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.
ARTRADietary supplement
Also called Glucosamine, Chondroitin sulfate
ARTRA (glucosamine and chondroitin sulfate)
| Study group | Role | What they receive |
|---|---|---|
| ARTRA | Patients with low back pain treated with ARTRA. Receives: Dietary Supplement: ARTRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity on Visual Analogue Scale
Measured: 3 months
Secondary outcomes (3)
Oswestry Disability Index
Measured: 3 months
Patient global assessment of efficacy
Measured: 3 months
NSAID consumption
Number of patients taking NSAIDs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unipharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurkirpal Singh, MD, Study chair, Irish Clinical Outcomes in Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990729
- Sponsor's protocol ID
- ARTRA-PMS-LBP/2012
- Status last verified
- Nov 2013
- First submitted
- 7 Oct 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care
- ClinicalTrials.gov ID
- NCT01990729
- Acronym / sponsor ID
- ARTRA-PMS-LBP/2012
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Unipharm, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Nov 2013 (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.
To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.
Detailed description
We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARTRA | – | Dietary Supplement: ARTRAPatients with low back pain treated with ARTRA. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain in ambulatory care
Key inclusion criteria (7 listed)
- Patients aged 40-65 years, inclusively.
- Pain intensity according to Visual Analogue Scale (VAS) > 3 points.
- Duration of back pain > 12 weeks.
- Pain reinforcement during movement in lumbar spine.
- Osteoarthritis, spondylarthrosis, osteochondrosis.
Key exclusion criteria (12 listed)
- History of allergic reactions to chondroprotectors.
- Participation in another clinical study within 30 days before screening or during this study.
- Fibromyalgia.
- Active neoplastic disease, history of neoplastic disease within 3 years before screening.
- Paget's disease.
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 |
|---|---|---|
| ARTRAAlso: Glucosamine, Chondroitin sulfateARTRA (glucosamine and chondroitin sulfate) | Dietary supplement | ARTRA |
Primary outcome
Pain Intensity
Time frame: 3 months
Pain intensity on Visual Analogue Scale
3 secondary outcomes
Oswestry Disability Index
Time frame: 3 months
Patient global assessment of efficacy
Time frame: 3 months
NSAID consumption
Time frame: 3 months
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 21 Nov 2013.
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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.
Gurkirpal Singh, MD study chair
Irish Clinical Outcomes in Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Unipharm, Inc. at 1 site in Russia.
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 7 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Pain Intensity (time frame: 3 months). 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 21 Nov 2013.