NCT00130949

Brief Summary

Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. This study will test the efficacy and safety of ALGRX 4975 in the treatment of patients with tennis elbow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

December 20, 2006

Status Verified

August 1, 2005

First QC Date

August 15, 2005

Last Update Submit

December 18, 2006

Conditions

Tennis Elbow

Keywords

Acute lateral epicondylitisTennis elbowCapsaicin

Outcome Measures

Primary Outcomes (1)

  • Pain induced by resisted wrist dorsiflexion 4 weeks after treatment

Secondary Outcomes (8)

  • Pain induced by resisted wrist dorsiflexion (other than 4 weeks)

  • Grip strength

  • Pain experienced during the grip strength test

  • Pain in elbow over previous 24 hours

  • Effect on work

  • +3 more secondary outcomes

Interventions

ALGRX 4975DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute lateral epicondylitis (LE) of less than 3 months duration (subjects with recurrent acute LE may be included).
  • A screening and baseline severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
  • Lidocaine responsive.
  • A systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively.

You may not qualify if:

  • Any clinically significant form of joint disease, elbow trauma or neuromuscular disorder at the elbow, other than acute LE.
  • Physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
  • Any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at less than or equal to 1000 mcg/day.
  • A medical condition other than LE that requires the use of a pain medication.
  • A peripheral sensory or motor neuropathy involving the upper extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortopedicko-Traumatologicka Klinika

Košice, 040 11, Slovakia

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Gabriel Vasko, MD PhD

    Ortopedicko-Traumatologicka Klinika, Kosice, Slovak Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 17, 2005

Study Start

November 1, 2004

Study Completion

November 1, 2005

Last Updated

December 20, 2006

Record last verified: 2005-08

Locations

SL(1)