Clinical trial NCT01990729: Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Unipharm, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back pain in ambulatory care

Brief 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.

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 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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Primary outcomes:
measure: Pain Intensity
timeFrame: 3 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Patient global assessment of efficacy
timeFrame: 3 months
measure: NSAID consumption
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: FGBU "State NII of Rheumatology" of RAMS
Study officials:
affiliation: Irish Clinical Outcomes in Research and Education
name: Gurkirpal Singh, MD
role: STUDY_CHAIR
References: