PainPhase 2NCT00404391
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
A Phase 2 study testing Hydrocodone/Acetaminophen Extended Release in people with Pain, run by Abbott at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Hydrocodone/Acetaminophen Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2003to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female ages 18 to 65
- Females must be of non-childbearing potential or practicing birth control
- Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
Who cannot join
- Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
- Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
- Is associated with any currently ongoing research study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site Ref # / Investigator 4994
Austin, Texas, 78705
Site Ref # / Investigator 4993
Owing Mills, Maryland, 21117
Site Ref # / Investigator 4995
Salt Lake City, Utah, 84117
Site Ref # / Investigator 4992
San Marcos, Texas, 78666
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
- Conditions
- Pain
- Being tested
- Hydrocodone/Acetaminophen Extended Release, Placebo
- Keywords
- Moderate to severe pain following bunionectomy surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone/Acetaminophen Extended ReleaseDrug
Also called ABT-712
1 tablet every 12 hours
Hydrocodone/Acetaminophen Extended ReleaseDrug
Also called ABT-712
2 tablets every 12 hours
PlaceboDrug
2 tablets every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: hydrocodone/acetaminophen extended release | Experimental | Not described Receives: Drug: Hydrocodone/Acetaminophen Extended Release |
| Arm 2: hydrocodone/acetaminophen extended release | Experimental | Not described Receives: Drug: Hydrocodone/Acetaminophen Extended Release |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
Pain relief measured by a 100mm Visual Analog Scale (VAS)
Measured: 12 hours
Secondary outcomes (1)
Time interval weighted sum of pain intensity difference (SPID)scores
Sum of pain intensity difference
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startOct 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rita Jain, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404391
- Sponsor's protocol ID
- M03-609
- Status last verified
- Jan 2011
- First submitted
- 26 Nov 2006
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT00404391
- Acronym / sponsor ID
- M03-609
- Conditions
- Pain
- Keywords
- Moderate to severe pain following bunionectomy surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 28 Nov 2006 (estimated)
- Results
- Not posted in the source record
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 is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: hydrocodone/acetaminophen extended release | Experimental | Drug: Hydrocodone/Acetaminophen Extended Release |
| Arm 2: hydrocodone/acetaminophen extended release | Experimental | Drug: Hydrocodone/Acetaminophen Extended Release |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ages 18 to 65
- Females must be of non-childbearing potential or practicing birth control
- Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
Key exclusion criteria (3 listed)
- Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
- Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
- Is associated with any currently ongoing research study
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 |
|---|---|---|
| Hydrocodone/Acetaminophen Extended ReleaseAlso: ABT-7121 tablet every 12 hours | Drug | Arm 1: hydrocodone/acetaminophen extended release |
| Hydrocodone/Acetaminophen Extended ReleaseAlso: ABT-7122 tablets every 12 hours | Drug | Arm 2: hydrocodone/acetaminophen extended release |
| Placebo2 tablets every 12 hours | Drug | placebo |
Primary outcome
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
Time frame: 12 hours
Pain relief measured by a 100mm Visual Analog Scale (VAS)
1 secondary outcome
Time interval weighted sum of pain intensity difference (SPID)scores
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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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.
Rita Jain, MD study director
Abbott
4 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 Hydrocodone/Acetaminophen Extended Release in people with Pain, run by Abbott at 4 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 3 inclusion and 3 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration (time frame: 12 hours). 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 19 Jan 2011; AzTrials last refreshed its copy on 6 Nov 2026.