CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 250 enrolled
Drug / intervention
Glucosamine sulphate +1 moredrug
Likely dose
Glucosamine sulfate 1500 mg orally once daily for 6 monthsAI-extracted
Key inclusion· 3
  • Low back pain persisting for more than 6 months
  • Age older than 25 years
  • MRI findings consistent with lumbar degenerative or osteoarthritic changes
Key exclusion· 9
  • Spinal stenosis accompanied by neurological deficits
  • Spinal prolapse accompanied by neurological deficits
  • Rheumatoid arthritis or psoriatic arthritis
  • History of old lumbar fractures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00404079
NCT00404079Phase 4Completed

Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings

Ullevaal University Hospital·interventional·Posted Nov 27, 2006·Updated Apr 29, 2011

In Brief

A Phase 4 clinical trial evaluating Glucosamine sulphate and Placebo for Low Back Pain. Completed, enrolled 250 participants across 1 site.

Detailed Summary

Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA. Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesNorway

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 27, 2006
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.6 years ago

Interventions

Glucosamine sulphatedrug

Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months

Placebodrug

Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months