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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014