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A Study for Moderate Osteoarthritis of the Knee (Flexsure)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478997
First Posted: November 24, 2011
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VitalgNetics
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.
November 17, 2011
November 24, 2011
May 16, 2012
August 2011
March 2012   (Final data collection date for primary outcome measure)
  • WOMAC - pain subscale [ Time Frame: 56 Days ]
  • Clinical Adverse Events [ Time Frame: 56 Days ]
  • Laboratory Adverse Events [ Time Frame: 56 Days ]
  • Assessment of Tolerability by the Subject [ Time Frame: 56 Days ]
Same as current
Complete list of historical versions of study NCT01478997 on ClinicalTrials.gov Archive Site
  • Visual Analog Scale - Pain [ Time Frame: 56 Days ]
  • Consumption of Rescue Medication [ Time Frame: 56 Days ]
  • Investigator's and Subject's Global Assessment [ Time Frame: 56 Days ]
  • WOMAC - Pain Subscale [ Time Frame: 56 Days ]
  • VAS - Pain [ Time Frame: 56 Days ]
  • Consumption of Rescue Medication [ Time Frame: 56 Days ]
  • Investigator's Global Assessment [ Time Frame: 56 Days ]
  • Subject's Global Assessment [ Time Frame: 56 Days ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01478997
SA/110114/FLX/OA
No
Not Provided
Not Provided
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