Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Pain, Postoperative
Eligibility:
All Genders
25-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participan...
Detailed Description
This study is a randomized (study drug assigned by chance), multicenter (when more than 1 hospital or medical school team work on a medical research study), active-controlled, parallel group (each gro...
Eligibility Criteria
Inclusion
- Participants who are scheduled to have standard primary (non-revision) unilateral (having to do with only 1 side of a structure) total knee replacement arthroplasty (TKRA-surgery to fix a joint) for non-inflammatory (no swelling, redness, and pain in tissues caused by injury or damage) degenerative joint disease (NIDJD)
- Participants who are capable of oral (having to do with the mouth) intake
- Women must be: postmenopausal (for at least 1 year), surgically sterile, abstinent (not having sexual intercourse), or practicing a highly effective method of birth control before participation in the study and who agree to continue to use the same method of birth control throughout the study in cases of women of childbearing potential
- Male participants must practice contraception, and must agree not to donate his sperms for 1 month after the last dose of study drug
- Participants who will complain of baseline pain of intensity of greater than or equal to 4 on 11-point numeric rating scale (NRS) measured within 1 hour prior to randomization (study drug assigned by chance) and a maximum of 6 hours after discontinuation of participant controlled analgesia (PCA) after at least 12 hours of application following TKRA
Exclusion
- Participants with Illness history (severe \[very serious, life threatening\] hepatic \[having to do with the liver\] failure, severe renal \[having to do with the kidney\] failure; severe respiratory depression; risk for mental fog with head injury or brain lesions \[abnormal area of tissue, such as a wound, sore, rash, or boil\]; digestive ulcer \[sore\], severe blood abnormalities; severe cardiac insufficiency; aspirin asthma \[asthmatic attack-breathing disorder in which there is a wheezing and difficulty in breathing; caused by non-steroidal anti-inflammatory drugs\] or history of aspirin asthma; history of epilepsy \[seizure disorder\]; rheumatism, significant psychiatric disorder or taking antipsychotic drugs for psychiatric treatment)
- Administration of disallowed therapy such as: administration of oral, patch, injection or local analgesics (drug used to control pain) acting centrally (the brain and the spinal cord) or peripherally (not central) before study drug administration after completion of PCA application, surgery is conducted simultaneously in addition to TKRA, administration of monoamine oxidase (MAO) inhibitors or discontinuation of the administration within 2 weeks, tricyclic antidepressants that may increase the seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) risk when concomitantly (given at the same time) administered, neuroleptics, or drugs that may lower the seizure threshold, use of sedatives (a medication to calm or make less anxious) other than that used for general anesthesia (loss of sensation or feeling) during surgery
- Participants who used any study drug or investigational medical device within 30 days before the start of the treatment
- Participants requiring postoperative intensive care unit (ICU) care
- Participants having hypersensitivity to tramadol or acetaminophen
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01814878
Start Date
November 1 2009
End Date
February 1 2011
Last Update
June 20 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.