A Study for Moderate Osteoarthritis of the Knee (Flexsure)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Flexsure Capsules
Placebo Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- Nasik
- Pune
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Flexsure Capsules
Carboxy Methyl Cellulose Capsules
Arm Description
Investigational Product
Placebo
Outcomes
Primary Outcome Measures
WOMAC - pain subscale
Clinical Adverse Events
Laboratory Adverse Events
Assessment of Tolerability by the Subject
Secondary Outcome Measures
Visual Analog Scale - Pain
Consumption of Rescue Medication
Investigator's and Subject's Global Assessment
Full Information
NCT ID
NCT01478997
First Posted
November 17, 2011
Last Updated
May 15, 2012
Sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborators
VitalgNetics
1. Study Identification
Unique Protocol Identification Number
NCT01478997
Brief Title
A Study for Moderate Osteoarthritis of the Knee
Acronym
Flexsure
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborators
VitalgNetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexsure Capsules
Arm Type
Experimental
Arm Description
Investigational Product
Arm Title
Carboxy Methyl Cellulose Capsules
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Flexsure Capsules
Other Intervention Name(s)
Paracetamol
Intervention Description
Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Capsules
Other Intervention Name(s)
Paracetamol
Intervention Description
Carboxy Methyl Cellulose
Primary Outcome Measure Information:
Title
WOMAC - pain subscale
Time Frame
56 Days
Title
Clinical Adverse Events
Time Frame
56 Days
Title
Laboratory Adverse Events
Time Frame
56 Days
Title
Assessment of Tolerability by the Subject
Time Frame
56 Days
Secondary Outcome Measure Information:
Title
Visual Analog Scale - Pain
Time Frame
56 Days
Title
Consumption of Rescue Medication
Time Frame
56 Days
Title
Investigator's and Subject's Global Assessment
Time Frame
56 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Bhakti Shinde, BAMS, PGDCR
Organizational Affiliation
Vedic Lifesciences Pvt. Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Nasik
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Facility Name
Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
12. IPD Sharing Statement
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A Study for Moderate Osteoarthritis of the Knee
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