CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
3ml-Rejuvinex +1 moredrug
Likely dose
3ml-Rejuvinexfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02492945
NCT02492945Phase 4Completed

Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study

Seoul National University Bundang Hospital·interventional·Posted Jul 9, 2015·Updated Apr 20, 2017

In Brief

A Phase 4 clinical trial evaluating 3ml-Rejuvinex and 3ml-15%-dextrose solution for Lateral Epicondylitis. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the lateral epicondylitis with ultrasonography-guided injection of the PDRN or dextrose solution. Condition: lateral epicondylitis Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as prolotherapy, active control Phase 4 Study type: Interventional Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer, Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with elbow epicondylitis in randomized double-blind active-control comparative study Estimated Enrollment: 40

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago

Interventions

3ml-Rejuvinexdrug

They take the three times of the ultrasonography-guided 3ml-Rejuvinex as a PDRN group for four weeks(0,2,4 weeks) under double-blind.

3ml-15%-dextrose solutiondrug

They take the three times of the ultrasonography-guided 3ml-15%-dextrose solution injections as a Dextrose group for four weeks(0,2,4 weeks) under double-blind.