Lateral Epicondylitis (Tennis Elbow)Phase 1/2NCT01668862
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
A Phase 1/2 study testing Autologous Human Platelet Lysate and Corticosteroid in people with Lateral Epicondylitis (Tennis Elbow), run by Kasiak Research Pvt. Ltd. at 1 site in India.
Trial summary
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Autologous Human Platelet Lysate and Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with clinical diagnosis of tennis elbow within the last 3 months
- Subjects both male and female, aged 18-60 years (both inclusive)
- Subjects who are willing to give informed consent and adhere to the study protocol
Who cannot join
- Subjects aged less than 18 and more than 60 years
- Subjects with autoimmune diseases
- Subjects with immuno-compromised system
- Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
- Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
- Subjects who have received treatment with corticosteroid injections within the last 6 months
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Kasiak Research Pvt Ltd
Thane, Maharashtra, 400610
Kaushal Shah, Phd, +91-22-4117472, kaushal.shah@kasiakresearch.com
About this study
Official title: A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Autologous Human Platelet Lysate, Corticosteroid
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Platelet LysateBiological
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
CorticosteroidDrug
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
| Study group | Role | What they receive |
|---|---|---|
| Study arm A | Other | Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space Receives: Biological: Autologous Human Platelet Lysate |
| Control Arm B | Other | Subjects will receive one injection of Corticosteroid in the lateral epicondyle space Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Score (VAS)
Measured: Day 0, Month 1, Month 2, End of Study - Month 3
Secondary outcomes (1)
Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
Measured: Day 0, End of study - Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasiak Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anant Joshi, Dr., Principal investigator, ASMINicolas Antao, Dr., Principal investigator, Hillway ClinicGauresh Palekar, Dr., Principal investigator, Surya Orthopedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668862
- Sponsor's protocol ID
- KRPL/HPL-TE/11-12/003
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
- ClinicalTrials.gov ID
- NCT01668862
- Acronym / sponsor ID
- KRPL/HPL-TE/11-12/003
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kasiak Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 20 Aug 2012 (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 multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm A | Other | Biological: Autologous Human Platelet LysateSubjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space |
| Control Arm B | Other | Drug: CorticosteroidSubjects will receive one injection of Corticosteroid in the lateral epicondyle space |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with clinical diagnosis of tennis elbow within the last 3 months
- Subjects both male and female, aged 18-60 years (both inclusive)
- Subjects who are willing to give informed consent and adhere to the study protocol
Key exclusion criteria (6 listed)
- Subjects aged less than 18 and more than 60 years
- Subjects with autoimmune diseases
- Subjects with immuno-compromised system
- Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
- Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
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 |
|---|---|---|
| Autologous Human Platelet LysateSubjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space | Biological | Study arm A |
| CorticosteroidSubjects will receive one injection of Corticosteroid in the lateral epicondyle space | Drug | Control Arm B |
Primary outcome
Change in Visual Analog Score (VAS)
Time frame: Day 0, Month 1, Month 2, End of Study - Month 3
1 secondary outcome
Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
Time frame: Day 0, End of study - Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
Anant Joshi, Dr. principal investigator
ASMI
Nicolas Antao, Dr. principal investigator
Hillway Clinic
Gauresh Palekar, Dr. principal investigator
Surya Orthopedic Clinic
1 site 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 Autologous Human Platelet Lysate and Corticosteroid in people with Lateral Epicondylitis (Tennis Elbow), run by Kasiak Research Pvt. Ltd. at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaushal Shah, Phd (+91-22-41173472, kaushal.shah@kasiakresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Score (VAS) (time frame: Day 0, Month 1, Month 2, End of Study - Month 3). 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 20 Aug 2012.