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Clinical Trials/CTRI/2011/07/001911
CTRI/2011/07/001911
Completed
Phase 3

A randomized double-blind placebo-controlled study to determine whether Flexsure is safe, tolerable and effective in relieving symptoms of moderate osteoarthritis of the knee. - None

Vital gNetics0 sites60 target enrollmentTBD
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ConditionsHealth Condition 1: null- Osteoarthritis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Osteoarthritis
Sponsor
Vital gNetics
Enrollment
60
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Vital gNetics

Eligibility Criteria

Inclusion Criteria

  • •1\.Diagnosed of OA of the knee according to the ACR clinical and radiographic criteria.
  • •2\.ARA functional class II or III.
  • •3\.Kellgren Lawrence radiological severity of Grade II, Grade III OA knee.
  • •4\.Maximal OA pain on movement, as measured on a 0\-100 Visual analog scale (VAS) should be 40 80 in the previous 24 hrs at screening and baseline visits.

Exclusion Criteria

  • •1\.Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease
  • •2\.BMI 35 kg/m2
  • •3\.Indication of surgery for OA knee
  • •4\.Arthroscopy of either knee in the past year
  • •5\.Use of analgesics or any other symptom\-relieving medication within 7 days of screening
  • •6\.Use of systemic steroids or herbal medication for OA within 4 weeks of screening
  • •7\.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
  • •8\.Administration of intra\-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
  • •9\.History of osteoporotic/ osteoarthritic fractures within the past 6 months
  • •10\.Pregnant or lactating women or women with inadequate contraceptive measures

Outcomes

Primary Outcomes

Not specified

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