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Status:

COMPLETED

ALGRX 4975 After Total Knee Replacement

Lead Sponsor:

AlgoRx Pharmaceuticals

Conditions:

Arthroplasty, Replacement, Knee

Knee Injuries

Eligibility:

All Genders

35-80 years

Phase:

PHASE2

Brief Summary

ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization...

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, study conducted in subjects undergoing unilateral TKA. Subjects will undergo a screening visit up to 28 days prior to surgery. A su...

Eligibility Criteria

Inclusion

  • The subject (male or female) is aged 35 - 80 years. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to administration of study drug; must be nonlactating; and must be willing to use adequate and reliable contraception throughout the study.
  • The subject is planned to undergo unilateral TKA.
  • The subject is willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
  • The subject is in good health and capable of undergoing TKA.
  • The subject has signed the Informed Consent approved by the Institutional Review Board (IRB).

Exclusion

  • The subject has a laboratory test value outside the accepted range unless approved by the Sponsor.
  • The subject is currently taking or has taken a chronic opioid (more than 30 consecutive days of daily use) for pain other than knee pain in the past two years.
  • The use of capsaicin, opioids, bupivacaine, ropivacaine, muscle relaxants, or acetaminophen is contraindicated in this subject (e.g., significant history of allergic reactions or intolerance to these or related substances).
  • The use of general anesthesia is contraindicated in this subject.
  • The subject is taking central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, or selective serotonin reuptake inhibitors (SSRIs) for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen is permitted if stable over at least 30 days. The use of lorazepam and other sleep medications is permitted. Administration of ketorolac tromethamine (Toradol®) is permitted preoperatively, intraoperatively, and postoperatively no later than 8 PM on the day of surgery.
  • The subject has a medical condition that, in the Investigator's opinion, could adversely impact the subject's participation or safety; conduct of the study; or interfere with the pain assessments, including fracture or active infection.
  • The subject has diabetes mellitus and HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes.
  • The subject has another painful physical condition that, in the opinion of the Investigator, may confound the assessments of postoperative pain or rehabilitation. The subject has a history of or current neuropathic pain condition.
  • The subject is planned to undergo bilateral TKA.
  • The subject has had arthroplasty (partial or total) of the index knee.
  • The subject has a history of drug, prescription medicine or alcohol abuse within the past 2 years.
  • The subject is taking an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days
  • The subject is taking any of the following medications: digoxin; all antiarrhythmics except beta-blockers; warfarin; theophylline preparations; aminoglycosides; anticonvulsants except benzodiazepines; and lithium.
  • The subject has taken an investigational product within 3 months prior to the first dose of study drug (Visit 2), or is scheduled to receive an investigational product other than ALGRX 4975, while participating in the study.
  • The subject has a known bleeding disorder or is taking agents affecting coagulation. Low dose aspirin is allowed as cardiac prophylaxis; NSAIDs, if stable for at least 30 days, are permitted; and deep venous thrombosis prophylaxis, of the surgeon's choice, is permitted postoperatively.
  • The subject has previously participated in a clinical study with ALGRX 4975.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

End Date :

December 1 2005

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00132392

Start Date

July 1 2005

End Date

December 1 2005

Last Update

December 20 2006

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Capstone Clinical Trials, Inc.

Birmingham, Alabama, United States, 35209