NCT02534558

Brief Summary

The team integrates experimental analyses of clinical and basic medicine and transgenic mice models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue homeostasis that alleviates tissue stiffness and maintains function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

5 years

First QC Date

April 13, 2015

Last Update Submit

February 5, 2017

Conditions

Keywords

MicroRNA-29shoulder stiffnessmir-29a

Outcome Measures

Primary Outcomes (1)

  • The microRNA expression, mRNA expression as a measure

    Differences among incidence, microRNA expression, mRNA expression of shoulder stiffness are analyzed using non-parametric student's t-test. P value of \< 0.05 is considered statistically significant.

    48hr

Study Arms (2)

miR-29a precursor oligonucleotide

EXPERIMENTAL

Effects of IL-1β, miR-29a precursor oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified

Biological: miR 29a

miR-29a antisense oligonucleotide

EXPERIMENTAL

Effects of IL-1β, miR-29a antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified

Biological: miR 29a

Interventions

miR 29aBIOLOGICAL

Effects of IL-1β, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified

miR-29a antisense oligonucleotidemiR-29a precursor oligonucleotide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 to 80 years
  • receiving surgery for open acromioplasty

You may not qualify if:

  • shoulder disorders caused by traumatic fracture
  • previous surgery
  • osteoarthritis
  • malignant disorders
  • hepatic disorders
  • renal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Study Officials

  • Yang-Jih Ko, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Yang Ko, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

August 27, 2015

Study Start

August 1, 2014

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations