PainPhase 2NCT00404222
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
A Phase 2 study testing Hydrocodone/Acetaminophen Extended-Release and Hydrocodone/Acetaminophen Immediate Release (NORCO®) in people with Pain, run by Abbott.
Trial 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… 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 and Hydrocodone/Acetaminophen Immediate Release (NORCO®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Feb 2006
- 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
- 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
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Pain
- Being tested
- Hydrocodone/Acetaminophen Extended-Release, Hydrocodone/Acetaminophen Immediate Release (NORCO®), Placebo
- Keywords
- Acute Pain following Bunionectomy
- 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 hydrocodone / acetaminophen extended release
2 tablets x 1
Hydrocodone/Acetaminophen Immediate Release (NORCO®)Drug
1 tablet q 4 hours x 3
PlaceboDrug
q 4 hours x 3
| Study group | Role | What they receive |
|---|---|---|
| hydrocodone / acetaminophen extended release | Experimental | Not described Receives: Drug: Hydrocodone/Acetaminophen Extended-Release |
| Hydrocodone/Acetaminophen Immediate Release (Norco ®) | Active comparator | Not described Receives: Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®) |
| 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.
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.
Measured: 12 hours
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
Measured: 12 hours
Secondary outcomes (5)
Time-interval weighted sum of pain relief (TOTPAR)
Measured: 12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Measured: 12 hours
Time to first noticeable pain relief (i.e., onset of pain relief)
Measured: 12 hours
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
Measured: 12 hours
Proportion of subjects experiencing meaningful pain relief after dosing
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 startNov 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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
- Single blind
- Enrolment
- 90 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
- NCT00404222
- Sponsor's protocol ID
- M05-772
- Status last verified
- Jul 2011
- First submitted
- 26 Nov 2006
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00404222
- Acronym / sponsor ID
- M05-772
- Conditions
- Pain
- Keywords
- Acute Pain following Bunionectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydrocodone / acetaminophen extended release | Experimental | Drug: Hydrocodone/Acetaminophen Extended-Release |
| Hydrocodone/Acetaminophen Immediate Release (Norco ®) | Active comparator | Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®) |
| 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 (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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: hydrocodone / acetaminophen extended release2 tablets x 1 | Drug | hydrocodone / acetaminophen extended release |
| Hydrocodone/Acetaminophen Immediate Release (NORCO®)1 tablet q 4 hours x 3 | Drug | Hydrocodone/Acetaminophen Immediate Release (Norco ®) |
| Placeboq 4 hours x 3 | Drug | Placebo |
Primary outcome
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
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
Time frame: 12 hours
5 secondary outcomes
Time-interval weighted sum of pain relief (TOTPAR)
Time frame: 12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time frame: 12 hours
Time to first noticeable pain relief (i.e., onset of pain relief)
Time frame: 12 hours
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
Time frame: 12 hours
Proportion of subjects experiencing meaningful pain relief after dosing
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 25 Jul 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrocodone/Acetaminophen Extended-Release and Hydrocodone/Acetaminophen Immediate Release (NORCO®) in people with Pain, run by Abbott.
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 5 inclusion and 8 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 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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). The study lists 2 primary outcomes in all. 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 25 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.