A Study for Moderate Osteoarthritis of the Knee (Flexsure)

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: Flexsure Capsules; Dietary supplement: Placebo Capsules

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

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Nasik, Maharashtra, India, 422002
      • Nasik
    • Pune, Maharashtra, India, 411004
      • Pune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Paracetamol
Placebo Comparator: Carboxy Methyl Cellulose Capsules; Placebo	Dietary supplement: Placebo Capsules; Carboxy Methyl Cellulose; Other Names: Paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
WOMAC - pain subscale	56 Days
Clinical Adverse Events	56 Days
Laboratory Adverse Events	56 Days
Assessment of Tolerability by the Subject	56 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale - Pain	56 Days
Consumption of Rescue Medication	56 Days
Investigator's and Subject's Global Assessment	56 Days

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Collaborators: VitalgNetics
• Investigators: Study Chair: Dr. Bhakti Shinde, BAMS, PGDCR, Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: SA/110114/FLX/OA