Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130949
Status:
COMPLETED
Last Update Posted:
2006-12-20
First Post:
2005-08-15
Brief Title:
ALGRX 4975 in the Treatment of Tennis Elbow
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Exploratory Evaluation of ALGRX 4975 in Subjects With Acute Lateral Epicondylitis
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles eg 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 subjects 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 subjects 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudra CT No 2004-001000-12 | None | None | None |