PainPhase 2NCT00404183
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
A Phase 2 study testing Extended-Release Hydrocodone/Acetaminophen 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 with placebo over a 5-week dosing period in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Extended-Release Hydrocodone/Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Mar 2005
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ages 21 to 75
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medications for osteoarthritis
- If female, must be of non-childbearing potential or practicing birth control
- Has sufficient pain to justify the use of round-the-clock opioids
Who cannot join
- Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
- Has certain medical conditions which may interfere with pain assessments
- Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- Has had certain infections, injuries or illnesses within the last month
- Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
- Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
- Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
- Cannot discontinue pain medications, even for a short time, prior to the study start
About this study
Official title: A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.
- Conditions
- Pain
- Being tested
- Extended-Release Hydrocodone/Acetaminophen, Placebo
- Keywords
- Pain associated with osteoarthritis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release Hydrocodone/AcetaminophenDrug
Also called ABT-712, hydrocodone/acetaminophen extended release
2 tablets BID
PlaceboDrug
2 tablets BID
| Study group | Role | What they receive |
|---|---|---|
| hydrocodone/acetaminophen extended release | Experimental | Not described Receives: Drug: Extended-Release Hydrocodone/Acetaminophen |
| 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.
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
Measured: 4 weeks
Secondary outcomes (1)
WOMAC Osteoarthritis Index, SF36
Osteoarthritis Index
Measured: 4 weeks
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 startAug 2004
- Primary completionMar 2005
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
- 120 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
- NCT00404183
- Sponsor's protocol ID
- M03-643
- 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, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00404183
- Acronym / sponsor ID
- M03-643
- Conditions
- Pain
- Keywords
- Pain associated with osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Mar 2005 (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 with placebo over a 5-week dosing period in patients with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocodone/acetaminophen extended release | Experimental | Drug: Extended-Release Hydrocodone/Acetaminophen |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ages 21 to 75
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medications for osteoarthritis
- If female, must be of non-childbearing potential or practicing birth control
- Has sufficient pain to justify the use of round-the-clock opioids
Key exclusion criteria (8 listed)
- Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
- Has certain medical conditions which may interfere with pain assessments
- Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- Has had certain infections, injuries or illnesses within the last month
- Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
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 |
|---|---|---|
| Extended-Release Hydrocodone/AcetaminophenAlso: ABT-712, hydrocodone/acetaminophen extended release2 tablets BID | Drug | hydrocodone/acetaminophen extended release |
| Placebo2 tablets BID | Drug | Placebo |
Primary outcome
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
Time frame: 4 weeks
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
1 secondary outcome
WOMAC Osteoarthritis Index, SF36
Time frame: 4 weeks
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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended-Release Hydrocodone/Acetaminophen 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 19 Jan 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?
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable"). (time frame: 4 weeks). 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.