Clinical trial NCT01478997: A Study for Moderate Osteoarthritis of the Knee
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: VitalgNetics
First posted: 2011-11-24
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: WOMAC - pain subscale
timeFrame: 56 Days
measure: Clinical Adverse Events
timeFrame: 56 Days
measure: Laboratory Adverse Events
timeFrame: 56 Days
measure: Assessment of Tolerability by the Subject
timeFrame: 56 Days
Secondary outcomes:
measure: Visual Analog Scale - Pain
timeFrame: 56 Days
measure: Consumption of Rescue Medication
timeFrame: 56 Days
measure: Investigator's and Subject's Global Assessment
timeFrame: 56 Days
Other outcomes:
Locations:
city: Nasik
country: India
facility: Nasik
state: Maharashtra
city: Pune
country: India
facility: Pune
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr. Bhakti Shinde, BAMS, PGDCR
role: STUDY_CHAIR
References: