Trial of the Use of Doxycycline After Rotator Cuff Repair | NCT02388477

Studies
Trial of the Use of Doxycycline After Rotator Cuff Repair

NCT02388477

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

May 9, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Rotator Cuff Injury

Interventions

Doxycycline
sugar pill

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Research idea tabled at this point.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2016

Last Update Posted Date

May 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aman Dhawan, MD, Assistant Professor of Surgery, Orthopaedics, Milton S. Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.

Detailed Description

Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doxycycline	Active Comparator	oral doxycycline, 2 weeks, twice a day,	Drug: Doxycycline
sugar pill	Placebo Comparator	sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.	Drug: sugar pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline	Drug	antibiotic used to treat infection	Doxycycline	Oracea,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rotator cuff ultrasound of post-operative shoulder	An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.	one year

Secondary Outcomes

Measure	Description	Time Frame
American Shoulder and Elbow Surgeons score	The survey is a standardized assessment of shoulder pain and function from the patient's perspective.	6 weeks, 3mos, 6mos, 1yr and 2 yr.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

repair of rotator cuff
age 18 and above
able to swallow capsules

Exclusion Criteria:

less than 18
unable to read or understand consent form
unable to swallow capsules
allergy to doxycycline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aman Dhawan, MD	Milton S. Hershey Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033	United States

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline
D000073893	Sugars

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided