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

November 15, 2013 updated by: Unipharm, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic low back pain in ambulatory care

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARTRA
Patients with low back pain treated with ARTRA.
Dietary supplement: ARTRA
ARTRA (glucosamine and chondroitin sulfate)
Other Names:
  • Chondroitin sulfate
  • Glucosamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 3 months
Pain intensity on Visual Analogue Scale
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 3 months
3 months
Patient global assessment of efficacy
Time Frame: 3 months
3 months
NSAID consumption
Time Frame: 3 months
Number of patients taking NSAIDs
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unipharm, Inc.

Investigators

  • Study Chair: Gurkirpal Singh, MD, Irish Clinical Outcomes in Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTRA-PMS-LBP/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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