Back to resultsBunionectomy Study (0000-063)
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
pregabalin
naproxen sodium
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Primary, unilateral, first metatarsal bunionectomy with osteotomy
Eligibility Criteria
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 = 60 mL 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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1: Pregabalin 300 mg
Arm 2: naproxen sodium 550 mg
Arm 3: Placebo
Arm Description
Outcomes
Primary Outcome Measures
Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery
Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Secondary Outcome Measures
Time to First Request of PCA Hydromorphone
Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Full Information
NCT ID
NCT00601458
First Posted
January 15, 2008
Last Updated
March 23, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00601458
Brief Title
Bunionectomy Study (0000-063)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Pregabalin and Naproxen Sodium on Postoperative Pain After Bunionectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Primary, unilateral, first metatarsal bunionectomy with osteotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Pregabalin 300 mg
Arm Type
Active Comparator
Arm Title
Arm 2: naproxen sodium 550 mg
Arm Type
Active Comparator
Arm Title
Arm 3: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Intervention Type
Drug
Intervention Name(s)
naproxen sodium
Other Intervention Name(s)
naproxen
Intervention Description
Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Primary Outcome Measure Information:
Title
Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery
Description
Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Time Frame
First 24 hours following surgery
Secondary Outcome Measure Information:
Title
Time to First Request of PCA Hydromorphone
Description
Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Time Frame
First 24 hours following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 = 60 mL 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21052881
Citation
Wang H, Gargano C, Lukac S, Jackson A, Beals C, Smiley P, Drexel M, Ruddy M, Herman G, Johnson-Levonas AO, Medve R, Webster L, Reicin A. An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics. Adv Ther. 2010 Dec;27(12):963-80. doi: 10.1007/s12325-010-0084-8. Epub 2010 Nov 3.
Results Reference
result
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Bunionectomy Study (0000-063)
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