Back to resultsA Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
Primary Purpose
Lateral Epicondylitis (Tennis Elbow)
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous Human Platelet Lysate
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis (Tennis Elbow)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Kasiak Research Pvt LtdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Study arm A
Control Arm B
Arm Description
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Outcomes
Primary Outcome Measures
Change in Visual Analog Score (VAS)
Secondary Outcome Measures
Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
Full Information
NCT ID
NCT01668862
First Posted
July 17, 2012
Last Updated
August 16, 2012
Sponsor
Kasiak Research Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01668862
Brief Title
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kasiak Research Pvt. Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis (Tennis Elbow)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm A
Arm Type
Other
Arm Description
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
Arm Title
Control Arm B
Arm Type
Other
Arm Description
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate
Intervention Description
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Primary Outcome Measure Information:
Title
Change in Visual Analog Score (VAS)
Time Frame
Day 0, Month 1, Month 2, End of Study - Month 3
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Patient rated tennis elbow evaluation (PRTEE Score)
Time Frame
Day 0, Month 1, Month 2, End of study-Month 3
Title
The American Shoulder and Elbow Society score
Time Frame
Dya 0, Month 1, Month 2, End of study-Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaushal Shah, Phd
Phone
+91-22-41173472
Email
kaushal.shah@kasiakresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anant Joshi, Dr.
Organizational Affiliation
ASMI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Antao, Dr.
Organizational Affiliation
Hillway Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gauresh Palekar, Dr.
Organizational Affiliation
Surya Orthopedic Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasiak Research Pvt Ltd
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
400610
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushal Shah, Phd
Phone
+91-22-4117472
Email
kaushal.shah@kasiakresearch.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
We'll reach out to this number within 24 hrs