OsteoarthritisPhase 1/2FlexsureNCT01478997
A Study for Moderate Osteoarthritis of the Knee
A Phase 1/2 study testing Flexsure Capsules in people with Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial summary
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Flexsure Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesIndia
- Study dates
- Aug 2011to Mar 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
Read the 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
- Conditions
- Osteoarthritis
- Being tested
- Flexsure Capsules, Placebo Capsules
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexsure CapsulesDietary supplement
Also called Paracetamol
Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
Placebo CapsulesDietary supplement
Also called Paracetamol
Carboxy Methyl Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Flexsure Capsules | Experimental | Investigational Product Receives: Dietary Supplement: Flexsure Capsules |
| Carboxy Methyl Cellulose Capsules | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC - pain subscale
Measured: 56 Days
Clinical Adverse Events
Measured: 56 Days
Laboratory Adverse Events
Measured: 56 Days
Assessment of Tolerability by the Subject
Measured: 56 Days
Secondary outcomes (3)
Visual Analog Scale - Pain
Measured: 56 Days
Consumption of Rescue Medication
Measured: 56 Days
Investigator's and Subject's Global Assessment
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VitalgNetics
- Responsible party
- Sponsor
- Investigators
- Dr. Bhakti Shinde, BAMS, PGDCR, Study chair, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478997
- Sponsor's protocol ID
- SA/110114/FLX/OA
- Acronym
- Flexsure
- Status last verified
- May 2012
- First submitted
- 17 Nov 2011
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01478997
- Acronym / sponsor ID
- Flexsure / SA/110114/FLX/OA
- Conditions
- Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- VitalgNetics
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexsure Capsules | Experimental | Dietary Supplement: Flexsure CapsulesInvestigational Product |
| Carboxy Methyl Cellulose Capsules | Placebo comparator | Dietary Supplement: Placebo CapsulesPlacebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexsure CapsulesAlso: ParacetamolFlexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days | Dietary supplement | Flexsure Capsules |
| Placebo CapsulesAlso: ParacetamolCarboxy Methyl Cellulose | Dietary supplement | Carboxy Methyl Cellulose Capsules |
Primary outcome
WOMAC - pain subscale
Time frame: 56 Days
Clinical Adverse Events
Time frame: 56 Days
Laboratory Adverse Events
Time frame: 56 Days
Assessment of Tolerability by the Subject
Time frame: 56 Days
3 secondary outcomes
Visual Analog Scale - Pain
Time frame: 56 Days
Consumption of Rescue Medication
Time frame: 56 Days
Investigator's and Subject's Global Assessment
Time frame: 56 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Bhakti Shinde, BAMS, PGDCR study chair
Vedic Lifesciences Pvt. Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Flexsure Capsules in people with Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC - pain subscale (time frame: 56 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.