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

NCT01990729 | Completed

• 1 other identifier: ARTRA-PMS-LBP/2012
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity on Visual Analogue Scale

  3 months

Secondary Outcomes (3)

• Oswestry Disability Index

  3 months

• Patient global assessment of efficacy

  3 months

• NSAID consumption

  3 months

Study Arms (1)

ARTRA

Patients with low back pain treated with ARTRA.

Dietary Supplement: ARTRA

Interventions

ARTRA DIETARY_SUPPLEMENT

ARTRA (glucosamine and chondroitin sulfate)

Also known as: Glucosamine, Chondroitin sulfate

ARTRA

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic low back pain in ambulatory care

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Unipharm, Inc.: lead

Study Sites (1)

FGBU "State NII of Rheumatology" of RAMS

Moscow, Russia

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

hydroquinone; Glucosamine; Chondroitin Sulfates

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Chondroitin; Glycosaminoglycans; Polysaccharides

Study Officials

• Gurkirpal Singh, MD

  Irish Clinical Outcomes in Research and Education

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: November 21, 2013
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

RU (1)