PainPhase 2NCT00935311
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
A Phase 2 study testing ABT-712 Extended-release and Hydrocodone/Acetaminophen Immediate-release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 3 sites in United States.
Trial summary
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- ABT-712 Extended-release and Hydrocodone/Acetaminophen Immediate-release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures
Who cannot join
- Allergies to study medications
- History of multiple drug allergies
- Unable to stop excluded medications
- Clinically significant laboratory abnormalities at Screening
- Significant medical condition at Screening
- Women who are pregnant or breast feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site Reference ID/Investigator# 20745
Austin, Texas, 78705
Site Reference ID/Investigator# 20744
Salt Lake City, Utah, 84117
Site Reference ID/Investigator# 20743
San Marcos, Texas, 78666
About this study
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
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.
Read the detailed description
Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).
- Conditions
- Pain
- Being tested
- ABT-712 Extended-release, Hydrocodone/Acetaminophen Immediate-release, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-712 Extended-releaseDrug
Also called Hydrocodone/acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-release
ABT-712 extended-release tablet
Hydrocodone/Acetaminophen Immediate-releaseDrug
Hydrocodone/acetaminophen immediate-release tablet
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| ABT-712 | Experimental | 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). Receives: Drug: ABT-712 Extended-release; Drug: Placebo |
| Hydrocodone/Acetaminophen | Active comparator | 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). Receives: Drug: Hydrocodone/Acetaminophen Immediate-release; Drug: Placebo |
| Placebo | Placebo comparator | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
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.
Measured: From time of first study drug administration to 12 hours following first study drug administration
Secondary outcomes (3)
TOTPAR (Total Pain Relief)
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.
Measured: From time of first study drug administration to 12 hours following first study drug administration
Time to First Rescue Medication
The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
Measured: From time of first study drug administration to 12 hours following first study drug administration
Participants With Adverse Events (AEs)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Quintana Diez, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935311
- Sponsor's protocol ID
- M11-063
- Status last verified
- Mar 2014
- First submitted
- 29 Jun 2009
- Last updated
- 8 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00935311
- Acronym / sponsor ID
- M11-063
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.
Detailed description
Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABT-712 | Experimental | Drug: ABT-712 Extended-release, Drug: Placebo1 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). |
| Hydrocodone/Acetaminophen | Active comparator | Drug: Hydrocodone/Acetaminophen Immediate-release, Drug: Placebo2 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). |
| Placebo | Placebo comparator | Drug: Placebo2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures
Key exclusion criteria (6 listed)
- Allergies to study medications
- History of multiple drug allergies
- Unable to stop excluded medications
- Clinically significant laboratory abnormalities at Screening
- Significant medical condition at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-712 Extended-releaseAlso: Hydrocodone/acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-releaseABT-712 extended-release tablet | Drug | ABT-712 |
| Hydrocodone/Acetaminophen Immediate-releaseHydrocodone/acetaminophen immediate-release tablet | Drug | Hydrocodone/Acetaminophen |
| PlaceboPlacebo tablet | Drug | ABT-712, Hydrocodone/Acetaminophen, Placebo |
Primary outcome
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.
3 secondary outcomes
TOTPAR (Total Pain Relief)
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Time to First Rescue Medication
Time frame: From time of first study drug administration to 12 hours following first study drug administration
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Quintana Diez, MD study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-712 Extended-release and Hydrocodone/Acetaminophen Immediate-release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.