ALGRX 4975 in the Treatment of Tennis Elbow

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Tennis Elbow

Clinical Trial Details

NCT number	NCT00130949
Study type	Interventional
Source	AlgoRx Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	November 2004
Completion date	November 2005

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02861183` - Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)	N/A
Recruiting	`NCT02304952` - Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia	N/A
Completed	`NCT02596659` - Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow	N/A
Completed	`NCT00674622` - Prolotherapy for the Treatment of Chronic Lateral Epicondylitis	Phase 2/Phase 3
Completed	`NCT06206109` - The Effect of Tendon Tears on Lateral Epicondylitis
Recruiting	`NCT04442321` - Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia	N/A
Not yet recruiting	`NCT04382144` - Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis	Phase 4
Recruiting	`NCT03863847` - A Neurofeedback Treatment for Chronic Musculoskeletal Pain	N/A
Completed	`NCT04576195` - Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia	N/A
Recruiting	`NCT02343809` - Diacutaneous Fibrolysis on Lateral Epicondylitis	Phase 3
Completed	`NCT05084664` - Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.	N/A
Completed	`NCT05039827` - Mobilition With Movement and Soft Tissue Mobiiztion in Tennis Elbow	N/A
Recruiting	`NCT00395616` - Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow	N/A
Recruiting	`NCT06116175` - Lateral Epicondylitis Continuous Radiofrequency Microtenotomy	N/A
Recruiting	`NCT05326763` - Functional and Electromyographical Changes After PRP or Dextrose Injection in Chronic Lateral Epicondylitis	Phase 3
Completed	`NCT04454060` - Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow
Enrolling by invitation	`NCT04445727` - Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis	N/A
Completed	`NCT04454047` - Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow——Mid-and-short Term Retrospective Study of 50 Cases
Completed	`NCT04395417` - Injection Therapy in Patients With Lateral Epicondylitis	N/A
Completed	`NCT04219488` - Investigating the Effects of Neuromobilization in Lateral Epicondylitis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.