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Bunionectomy Study
This study has been completed.
Study NCT00601458   Information provided by Merck
First Received: January 15, 2008   Last Updated: February 5, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

January 15, 2008
February 5, 2009
July 2007
Reduction in the total dose of PCA hydromorphone use [ Time Frame: First 24 hours following surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601458 on ClinicalTrials.gov Archive Site
Time to first request of PCA hydromorphone [ Time Frame: First 24 hours following surgery ] [ Designated as safety issue: No ]
Same as current
 
Bunionectomy Study
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Pregabalin and Naproxen Sodium on Postoperative Pain After Bunionectomy

We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.

 
Phase I
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Acute Pain
  • Drug: pregabalin
  • Drug: naproxen sodium
  • Drug: Comparator: Placebo (unspecified)
  • Active Comparator: Arm 1: pregabalin
  • Active Comparator: Arm 2: naproxen sodium
  • Placebo Comparator: Arm 3: Pbo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
February 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is a man or woman between 18 and 65 years of age
  • For Women of Child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit
  • Patient is scheduled to have a bunionectomy
  • Patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up
  • Patient is capable of operating a Patient Controlled Analgesia device

Exclusion Criteria:

  • Patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery
  • Patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs
  • Patient has an estimated creatinine clearance of < or = 60mL per min
  • Patient has a history of drug abuse or dependence, or patient has a positive urine drug screen
  • Patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)
Both
18 Years to 65 Years
No
 
 
 
 
NCT00601458
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
063
Merck
 
Study Director: Medical Monitor Merck
Merck
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.