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)
Sponsor study identifier
interventional
20
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2012
Actual (reported)August 20, 2012
Actual (reported)October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Visual Analog Score (VAS)
Day 0, Month 1, Month 2, End of Study - Month 3
Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
Day 0, End of study - Month 3
Patient rated tennis elbow evaluation (PRTEE Score)
Day 0, Month 1, Month 2, End of study-Month 3
The American Shoulder and Elbow Society score
Dya 0, Month 1, Month 2, End of study-Month 3
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
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
Kasiak Research Pvt Ltd
Thane, Maharashtra, 400610, India
Anant Joshi, Dr.
ASMI
Nicolas Antao, Dr.
Hillway Clinic
Gauresh Palekar, Dr.
Surya Orthopedic Clinic
First Submitted
July 17, 2012
First Posted
August 20, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 20, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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