Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain
Information source: Unipharm, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain
Intervention: ARTRA (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Unipharm, Inc. Official(s) and/or principal investigator(s): Gurkirpal Singh, MD, Study Chair, Affiliation: Irish Clinical Outcomes in Research and Education
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.
Clinical Details
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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Pain Intensity
Secondary outcome: Oswestry Disability IndexPatient global assessment of efficacy NSAID consumption
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients aged 40-65 years, inclusively.
2. Pain intensity according to Visual Analogue Scale (VAS) > 3 points.
3. Duration of back pain > 12 weeks.
4. Pain reinforcement during movement in lumbar spine.
5. Osteoarthritis, spondylarthrosis, osteochondrosis.
6. Given written Informed consent form for participation in the study.
7. Treatment with ARTRA
Exclusion Criteria:
1. History of allergic reactions to chondroprotectors.
2. Participation in another clinical study within 30 days before screening or during
this study.
3. Fibromyalgia.
4. Active neoplastic disease, history of neoplastic disease within 3 years before
screening.
5. Paget's disease.
6. Degenerative spondylolisthesis.
7. Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle
relaxant drugs for more than one week prior screening.
8. History of alcohol or drug abuse.
9. Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face
and extremities edema, dizziness and headache.
10. 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
11. Clinically significant renal disorders.
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Locations and Contacts
FGBU "State NII of Rheumatology" of RAMS, Moscow, Russian Federation
Additional Information
Starting date: July 2010
Last updated: November 15, 2013
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