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Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain

NCT ID: NCT01990729

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

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Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARTRA

Patients with low back pain treated with ARTRA.

ARTRA

Intervention Type DIETARY_SUPPLEMENT

ARTRA (glucosamine and chondroitin sulfate)

Interventions

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ARTRA

ARTRA (glucosamine and chondroitin sulfate)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Glucosamine Chondroitin sulfate

Eligibility Criteria

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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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Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unipharm, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gurkirpal Singh, MD

Role: STUDY_CHAIR

Irish Clinical Outcomes in Research and Education

Locations

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FGBU "State NII of Rheumatology" of RAMS

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ARTRA-PMS-LBP/2012

Identifier Type: -

Identifier Source: org_study_id