NCT01478997

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

November 17, 2011

Last Update Submit

May 15, 2012

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • WOMAC - pain subscale

    56 Days

  • Clinical Adverse Events

    56 Days

  • Laboratory Adverse Events

    56 Days

  • Assessment of Tolerability by the Subject

    56 Days

Secondary Outcomes (3)

  • Visual Analog Scale - Pain

    56 Days

  • Consumption of Rescue Medication

    56 Days

  • Investigator's and Subject's Global Assessment

    56 Days

Study Arms (2)

Flexsure Capsules

EXPERIMENTAL

Investigational Product

Dietary Supplement: Flexsure Capsules

Carboxy Methyl Cellulose Capsules

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo Capsules

Interventions

Flexsure CapsulesDIETARY_SUPPLEMENT

Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days

Also known as: Paracetamol
Flexsure Capsules
Placebo CapsulesDIETARY_SUPPLEMENT

Carboxy Methyl Cellulose

Also known as: Paracetamol
Carboxy Methyl Cellulose Capsules

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nasik

Nashik, Maharashtra, 422002, India

Location

Pune

Pune, Maharashtra, 411004, India

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dr. Bhakti Shinde, BAMS, PGDCR

    Vedic Lifesciences Pvt. Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 24, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

IN(2)