Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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|ClinicalTrials.gov Identifier: NCT00935311|
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : March 7, 2014
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: ABT-712 Extended-release Drug: Hydrocodone/Acetaminophen Immediate-release Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Third Molar Tooth Extraction|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Drug: ABT-712 Extended-release
ABT-712 extended-release tablet
Active Comparator: Hydrocodone/Acetaminophen
2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
Drug: Hydrocodone/Acetaminophen Immediate-release
Hydrocodone/acetaminophen immediate-release tablet
Placebo Comparator: Placebo
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
- 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.
- 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.
- Time to First Rescue Medication [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ]The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
- Participants With Adverse Events (AEs) [ Time Frame: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days). ]An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935311
|United States, Texas|
|Site Reference ID/Investigator# 20745|
|Austin, Texas, United States, 78705|
|Site Reference ID/Investigator# 20743|
|San Marcos, Texas, United States, 78666|
|United States, Utah|
|Site Reference ID/Investigator# 20744|
|Salt Lake City, Utah, United States, 84117|
|Study Director:||Pedro Quintana Diez, MD||AbbVie|