- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333722
Acute Pain Study Following Bunionectomy
A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.
After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Site Reference ID/Investigator# 51464
-
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Texas
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Austin, Texas, United States, 78705
- Site Reference ID/Investigator# 51602
-
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Utah
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Salt Lake City, Utah, United States, 84117
- Site Reference ID/Investigator# 51344
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
Exclusion Criteria:
- Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
- Drug allergies to hydrocodone, acetaminophen
- Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
placebo, 1 oral tablet every 12 hours
|
Placebo tablet
|
EXPERIMENTAL: Hydrocodone/Acetaminophen Extended Release
hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
|
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable".
The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline.
The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
|
From time of first study drug administration to 12 hours following first study drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Perceptible and Meaningful Pain Relief
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
|
The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
|
From time of first study drug administration to 12 hours following first study drug administration
|
TOTPAR (Total Pain Relief)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
|
TOTPAR was the time-interval weighted sum of pain relief.
Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief.
Higher mean TOTPAR scores indicate better pain relief.
The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
|
From time of first study drug administration to 12 hours following first study drug administration
|
SPRID (Pain Relief and Pain Intensity Difference)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
|
SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: "My pain at this time is…" with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain).
Higher mean SPRID scores indicated better pain control.
The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
|
From time of first study drug administration to 12 hours following first study drug administration
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- M12-169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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