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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
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis
 Dietary Supplement: Flexsure Capsules
Dietary Supplement: Placebo Capsules
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Vedic Lifesciences Pvt. Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 76
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flexsure Capsules
Investigational Product
 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
Placebo Comparator: Carboxy Methyl Cellulose Capsules
Placebo
 Dietary Supplement: Placebo Capsules
Carboxy Methyl Cellulose
Other Name: Paracetamol

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478997

Locations
India
Nasik
Nasik, Maharashtra, India, 422002
Pune
Pune, Maharashtra, India, 411004
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
VitalgNetics
Investigators
Study Chair: Dr. Bhakti Shinde, BAMS, PGDCR Vedic Lifesciences Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01478997     History of Changes
Other Study ID Numbers: SA/110114/FLX/OA
Study First Received: November 17, 2011
Last Updated: May 15, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Carboxymethylcellulose Sodium
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013