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A Study for Moderate Osteoarthritis of the Knee (Flexsure)

This study has been completed.
Sponsor:
Collaborator:
VitalgNetics
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01478997
First received: November 17, 2011
Last updated: May 15, 2012
Last verified: May 2012

November 17, 2011
May 15, 2012
August 2011
March 2012   (final data collection date for primary outcome measure)
  • WOMAC - pain subscale [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Clinical Adverse Events [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
  • Laboratory Adverse Events [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
  • Assessment of Tolerability by the Subject [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01478997 on ClinicalTrials.gov Archive Site
  • Visual Analog Scale - Pain [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Consumption of Rescue Medication [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Investigator's and Subject's Global Assessment [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • WOMAC - Pain Subscale [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • VAS - Pain [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Consumption of rescue medication [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Investigator's Global Assessment [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
  • Subject's Global Assessment [ Time Frame: 56 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study for Moderate Osteoarthritis of the Knee
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee

This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.

Primary efficacy variable:

Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale

Secondary efficacy variables:

  • Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale
  • Number of patients showing a 20% reduction from baseline in VAS-pain
  • Number of patients showing a 50% reduction from baseline in VAS- pain
  • Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo
  • Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only)
  • Consumption of rescue medication
  • Investigator's Global assessment of efficacy
  • Subject's global assessment of efficacy
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Dietary Supplement: Flexsure Capsules
    Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
    Other Name: Paracetamol
  • Dietary Supplement: Placebo Capsules
    Carboxy Methyl Cellulose
    Other Name: Paracetamol
  • Experimental: Flexsure Capsules
    Investigational Product
    Intervention: Dietary Supplement: Flexsure Capsules
  • Placebo Comparator: Carboxy Methyl Cellulose Capsules
    Placebo
    Intervention: Dietary Supplement: Placebo Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ambulatory male or female patients aged 30-65 years, and diagnosed of OA of the knee according to the ACR clinical and radiographic criteria
  • ARA functional class II or III
  • Kellgren Lawrence radiological severity of Grade II, Grade III OA knee
  • Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be more than 40 and less than 80 in the previous 24 hrs at screening and baseline visits

Exclusion Criteria:

  • 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
  • BMI >35 kg/m2
  • Indication of surgery for OA knee
  • Arthroscopy of either knee in the past year
  • Use of analgesics or any other symptom-relieving medication within 7 days of screening
  • Use of systemic steroids or herbal medication for OA within 4 weeks of screening
  • Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
  • Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
  • History of osteoporotic/ osteoarthritic fractures within the past 6 months
  • Pregnant or lactating women or women with inadequate contraceptive measures
  • Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction)
  • Presence of any clinically significant laboratory anomaly
  • Known cases of AIDS (HIV positive)
  • History of Coronary Angioplasty/CABG within the past 2 years
  • Moderate to severe peripheral neuropathy or other neurological disorders
  • Alcohol abuse, medication or drug dependence
  • Concurrent or previous participation in a clinical study within previous 6 weeks
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01478997
SA/110114/FLX/OA
No
Vedic Lifesciences Pvt. Ltd.
Vedic Lifesciences Pvt. Ltd.
VitalgNetics
Study Chair: Dr. Bhakti Shinde, BAMS, PGDCR Vedic Lifesciences Pvt. Ltd.
Vedic Lifesciences Pvt. Ltd.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP