NCT00631501

Brief Summary

Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs. This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks. Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

March 7, 2008

Status Verified

February 1, 2008

First QC Date

February 27, 2008

Last Update Submit

February 27, 2008

Conditions

Lateral Epicondylalgia (Tennis Elbow)

Keywords

tendinopathytennis elbowlateral epicondylitislateral epicondylalgiaMMP-inhibitor

Outcome Measures

Primary Outcomes (1)

  • Pain (VAS)

Study Arms (2)

2

PLACEBO COMPARATOR
Drug: Placebo

Doxycycline

EXPERIMENTAL

100 mg twice daily

Drug: Doxycycline

Interventions

PlaceboDRUG
2
DoxycyclineDRUG
Doxycycline

Eligibility Criteria

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

You may qualify if:

  • Age 18-65
  • Pain at the lateral side of the elbow ≥8 weeks
  • Local tenderness on palpation of the lateral epicondyle
  • Pain on resisted extension of the wrist

You may not qualify if:

  • Rheumatic disorder
  • History of fibromyalgia or generalised pain
  • Elbow surgery (on the painful side)
  • Active infection
  • Glucocorticoid treatment during the duration of symtoms of epicondylalgia
  • NSAID use within 1 w before presentation and during the study
  • Pregnancy
  • Taking drug that might interact with doxycycline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Orthopaedics, Kaunas Medical University

Kaunas, Kaunas County, Lithuania

RECRUITING

MeSH Terms

Conditions

Tennis ElbowTendinopathy

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Elbow TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Central Study Contacts

Alfredas Smailys, MD, PhD

CONTACT

+370 37 327201smailys@takas.lt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Last Updated

March 7, 2008

Record last verified: 2008-02

Locations

LI(1)