A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hydrocodone/Acetaminophen Extended-Release
Hydrocodone/Acetaminophen Immediate Release (NORCO®)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Acute Pain following Bunionectomy
Eligibility Criteria
Inclusion Criteria:
- Males and females ages 18 to 65
- Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
- Must meet specific pain intensity criteria on the morning after surgery
- Willing to remain at the study center 2 days following surgery
- If female, must be of non-child bearing potential or practicing birth control
Exclusion Criteria:
- Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
- Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Has a history of or currently has any active seizure disorder
- Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
- Has been diagnosed with cancer within the past 3 years
- Requires treatment with certain drugs for depression or psychiatric disorders
- Has specific clinically significant illnesses or laboratory abnormalities
- Received corticosteroid treatment or any investigational drug within a specific timeframe.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Immediate Release (Norco ®)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
Secondary Outcome Measures
Time-interval weighted sum of pain relief (TOTPAR)
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time to first noticeable pain relief (i.e., onset of pain relief)
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
Proportion of subjects experiencing meaningful pain relief after dosing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404222
Brief Title
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Official Title
A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Acute Pain following Bunionectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydrocodone / acetaminophen extended release
Arm Type
Experimental
Arm Title
Hydrocodone/Acetaminophen Immediate Release (Norco ®)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen Extended-Release
Other Intervention Name(s)
hydrocodone / acetaminophen extended release
Intervention Description
2 tablets x 1
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen Immediate Release (NORCO®)
Intervention Description
1 tablet q 4 hours x 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
q 4 hours x 3
Primary Outcome Measure Information:
Title
The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
Time Frame
12 hours
Title
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Time-interval weighted sum of pain relief (TOTPAR)
Time Frame
12 hours
Title
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time Frame
12 hours
Title
Time to first noticeable pain relief (i.e., onset of pain relief)
Time Frame
12 hours
Title
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
Time Frame
12 hours
Title
Proportion of subjects experiencing meaningful pain relief after dosing
Time Frame
12 hours
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:
Males and females ages 18 to 65
Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
Must meet specific pain intensity criteria on the morning after surgery
Willing to remain at the study center 2 days following surgery
If female, must be of non-child bearing potential or practicing birth control
Exclusion Criteria:
Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
Has a history of or currently has any active seizure disorder
Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
Has been diagnosed with cancer within the past 3 years
Requires treatment with certain drugs for depression or psychiatric disorders
Has specific clinically significant illnesses or laboratory abnormalities
Received corticosteroid treatment or any investigational drug within a specific timeframe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Jain, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
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