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ALGRX 4975 in the Treatment of Tennis Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00130949
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : December 20, 2006
Sponsor:
Information provided by:
AlgoRx Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 15, 2005
First Posted Date  ICMJE August 17, 2005
Last Update Posted Date December 20, 2006
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2005)
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment.
Change History Complete list of historical versions of study NCT00130949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2005)
  • 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
  • Tenderness elicited by investigator or designee
  • Subjects' global impression of change
  • Secondary outcomes are evaluated at 1, 2, 4, 8 and 12 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ALGRX 4975 in the Treatment of Tennis Elbow
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase II, Exploratory Evaluation of ALGRX 4975 in Subjects With Acute Lateral Epicondylitis
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.
Detailed Description

Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per 1000 annually and tends to involve the subject’s dominant side. It typically results from repetitive arm movement with over use of muscles leading to small tears in the tendons attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on or around the lateral epicondyle may radiate down the subject’s arm. Gripping or extending the wrist often intensifies the pain.

More than 40 possible treatments have been proposed, reflecting a lack of consensus about optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat tennis elbow, but there are no trials to date that have compared them with other painkillers and one study found no clinically important benefit over placebo. Use of corticosteroid injections provides mixed results in relief of pain and at times insufficient evidence to support their use. Although complications associated with steroid injection are relatively uncommon, when a complication does occur, it can result in severe and disabling consequences for the subject. A small proportion of subjects fail to respond to only one injection of corticosteroid and some subjects who initially improved at four weeks had worse symptoms by six months.

This study has been designed to evaluate the safety and efficacy of a single soft tissue injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute LE.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Tennis Elbow
Intervention  ICMJE Drug: ALGRX 4975
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 15, 2005)
45
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00130949
Other Study ID Numbers  ICMJE 4975-2-005-2
Eudra CT No : 2004-001000-12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AlgoRx Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabriel Vasko, MD PhD Ortopedicko-Traumatologicka Klinika, Kosice, Slovak Republic
PRS Account AlgoRx Pharmaceuticals
Verification Date August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP