Moderate to Severe Chronic, Non-malignant PainPhase 3NCT00195728

Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain

A Phase 3 study testing Hydrocodone/Acetaminophen on Extended Release in people with Moderate to Severe Chronic, Non-malignant Pain, run by Abbott at 76 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Moderate to Severe Chronic, Non-malignant Pain
What is being tested?: Hydrocodone/Acetaminophen on Extended Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 431 participants
Where: 76 sitesUnited States
Study dates: Jun 2005to Dec 2006
Phase: Phase 3
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 and Females between 21 and 75 years of age
Females must be of non-child bearing potential or practicing birth control
Moderate to severe mechanical low back pain OR moderate to severe OA of the hip or knee pain
Require medicine for pain the majority of days in the previous 3 months, AND for at least 4 days per week, during the previous 4 weeks.
Pain is not controlled with non-opioid analgesics or is contraindicated due to side effects and/or currently receiving opioid therapy equivalent to 40 mg/day of morphine or less

Who cannot join

Pregnant and/or breastfeeding females or females planning to become pregnant during the course of the study
Incapacitated, bedridden, or confined to a wheelchair permitting little or no self-care
Injury to the index joint or lower back within 3 months of study
History of any of the following:
Major surgery to the lower back within the last 5 years OR
Joint replacement/reconstruction to the index joint OR

Show all 36Show fewer

Arthroscopic or open surgery to the index joint within the last year OR
Any surgery within 3 months of study
Osteoporotic compression fracture, traumatic vertebral fracture or invasive intervention for low back pain within the last year.
Abnormal neurological exam, or lower extremity symptoms characteristic of neurogenic pain
History of inflammatory or infectious arthritis, tumors or infections of spinal cord, spinal stenosis, fibromyalgia or other chronic painful condition
Severe gastrointestinal narrowing
History of peritonitis, cystic fibrosis, chronic intestinal eudoobstruction, or Meckel's diverticulum.
Has received
Oral, intramuscular (IM), intravenous (IV) or non-index joint intra- articular corticosteroids within 1 month of study OR
Intra-articular corticosteroids at the index joint or epidural corticosteroids to the lower back region within 2 months of study, OR
Viscosupplementation therapy to index joint within 4 months of study
History of drug (licit or illicit) or alcohol abuse/addiction
Positive result for drugs of abuse at screening.
Chronic heavy drinker, consuming more than 4 alcoholic drinks per day.
History of malnutrition or starvation or is likely to fast for more than 4 consecutive days during the course of the study.
Medical condition or illness other than OA/CLBP, which is not well controlled
History of allergic reaction or a clinically significant sensitivity or intolerance to opioids and/or acetaminophen.
Newly diagnosed medical condition
Clinically significant infection/injury/illness within 1 month of study
Receiving systemic chemotherapy, or has an active malignancy of any type, or has been diagnosed with cancer within the past 5 years. Basal cell carcinoma of the skin that has been successfully treated will be permitted.
Known or suspected history of Human Immunodeficiency Virus.
Positive Hepatitis Screen
Clinically significant abnormalities in clinical chemistry, hematology or urinalysis
Received any investigational drug within 1 month of study
History of major psychiatric disorder
Active or uncontrolled seizure disorder.
Requires treatment with monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants during the course of the study.
Surgical procedure planned, or scheduled during the course of this study.
Ongoing workman's compensation claim or litigation.
Previous participation in the M03-666 study.

Trial locations and contacts

76 sites in 1 country.

City, postcode or hospital

76 sites in 1 country

United States76 sites

Site Reference # / Investigator 1744
Arlington Heights, Illinois, 60005
Site Ref # / Investigator 1692
Austin, Texas, 78705
Site Reference # / Investigator 1722
Austin, Texas, 78728
Site Reference # / Investigator 1794
Beaver, Pennsylvania, 15009
Site Reference # / Investigator 1726
Binghamton, New York, 13901
Site Ref # / Investigator 1711
Bristol, Connecticut, 06010
Site Ref # / Investigator 2555
Carmichael, California, 95608
Site Reference # / Investigator 1729
Chandler, Arizona, 85224
Site Reference # / Investigator 1708
Charlotte, North Carolina, 28210
Site Reference # / Investigator 1691
Chicago, Illinois, 60612
Site Reference # / Investigator 1689
Cincinnati, Ohio, 45227
Site Ref # / Investigator 1694
Cincinnati, Ohio, 45236
Site Reference # / Investigator 1723
Clearwater, Florida, 33756
Site Ref # / Investigator 1813
Clearwater, Florida, 33761
Site Ref # / Investigator 1816
Cleveland, Ohio, 44122
Site Reference # / Investigator 1690
Colorado Springs, Colorado, 80904
Site Reference # / Investigator 1757
Cordova, Tennessee, 38018
Site Reference # / Investigator 2425
Dallas, Texas, 75235
Site Reference # / Investigator 1718
DeLand, Florida, 32720
Site Reference # / Investigator 1749
Duncansville, Pennsylvania, 16635
Site Reference # / Investigator 1752
Erie, Pennsylvania, 16508-1256
Site Reference # / Investigator 1714
Evansville, Indiana, 47714
Site Reference # / Investigator 1688
Fair Oaks, California, 95628
Site Ref # / Investigator 1707
Fall River, Massachusetts, 02720
Site Reference # / Investigator 1699
Fort Worth, Texas, 76135
Site Ref # / Investigator 1696
Huntsville, Alabama, 35801
Site Ref # / Investigator 1792
Jackson, Mississippi, 39202
Site Ref # / Investigator 1725
Killeen, Texas, 76543
Site Reference # / Investigator 1705
Las Vegas, Nevada, 89104
Site Reference # / Investigator 1791
Las Vegas, Nevada, 89123
Site Ref # / Investigator 1713
Littleton, Colorado, 80120
Site Reference # / Investigator 1819
Longwood, Florida, 32779
Site Reference # / Investigator 1709
Mechanicsburg, Pennsylvania, 17055
Site Reference # / Investigator 1701
Medford, New Jersey, 08055
Site Reference # / Investigator 1702
Mesa, Arizona, 85210
Site Ref # / Investigator 1739
Metairie, Louisiana, 70006
Site Reference # / Investigator 1809
Miami, Florida, 33156
Site Reference # / Investigator 1738
Miami, Florida, 33173
Site Ref # / Investigator 1730
Monroe, North Carolina, 28112
Site Reference # / Investigator 1815
New York, New York, 10022
Site Ref # / Investigator 1733
Norfolk, Virginia, 23502-9921
Site Reference # / Investigator 1715
Oklahoma City, Oklahoma, 73103
Site Ref # / Investigator 1722
Omaha, Nebraska, 68134
Site Ref # / Investigator 1774
Omaha, Nebraska, 68134
Site Reference # / Investigator 1789
Omaha, Nebraska, 68134
Site Ref # / Investigator 1716
Orlando, Florida, 32806
Site Reference # / Investigator 1810
Owings Mills, Maryland, 21117
Site Reference # / Investigator 1755
Palm Harbor, Florida, 34684
Site Reference # / Investigator 1790
Pasadena, California, 21122
Site Ref # / Investigator 1814
Pembroke Pines, Florida, 33024
Site Reference # / Investigator 1745
Peoria, Arizona, 85381
Site Reference # / Investigator 1737
Plantation, Florida, 33324
Site Reference # / Investigator 2423
Portland, Oregon, 97239
Site Reference # / Investigator 1741
Raleigh, North Carolina, 27609
Site Reference # / Investigator 1732
Salt Lake City, Utah, 84102
Site Reference # / Investigator 1740
Salt Lake City, Utah, 84109
Site Reference # / Investigator 1710
San Angelo, Texas, 76904
Site Reference # / Investigator 1686
San Antonio, Texas, 78209
Site Reference # / Investigator 2426
San Antonio, Texas, 78217
Site Reference # / Investigator 1808
San Antonio, Texas, 78229
Site Reference # / Investigator 1735
San Diego, California, 92108
Site Reference # / Investigator 1775
San Luis Obispo, California, 93401
Site Ref # / Investigator 1742
Santa Ana, California, 92705
Site Reference # / Investigator 1727
Selmer, Tennessee, 38375
Site Reference # / Investigator 1721
St Louis, Missouri, 63117
Site Ref # / Investigator 1812
St Louis, Missouri, 63141
Site Reference # / Investigator 2424
St Louis, Missouri, 63141
Site Reference # / Investigator 1747
St. Petersburg, Florida, 33702
Site Ref # / Investigator 1754
Tarzana, California, 91356
Site Ref # / Investigator 1697
Tempe, Arizona, 85282
Site Ref # / Investigator 1818
Tempe, Arizona, 85282
Site Reference # / Investigator 2461
Trenton, New Jersey, 08629-1986
Site Reference # / Investigator 1795
Tucson, Arizona, 85741
Site Reference # / Investigator 1719
Virginia Beach, Virginia, 23455
Site Reference # / Investigator 1743
Wellesley Hills, Massachusetts, 02481-2106
Site Reference # / Investigator 1700
Whittier, California, 90601

Other trials in United States

About this study

Official title: An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain

The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.

Conditions: Moderate to Severe Chronic, Non-malignant Pain
Being tested: Hydrocodone/Acetaminophen on Extended Release
Keywords: Hydrocodone/Acetaminophen, Vicodin CR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrocodone/Acetaminophen on Extended ReleaseDrug
Also called ABT-712
2 tablets twice daily

Study groups in NCT00195728
Study group	Role	What they receive
hydrocodone/acetaminophen extended release	Experimental	Not described Receives: Drug: Hydrocodone/Acetaminophen on Extended Release

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety evaluation
Long term safety
Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Dec 2006

First posted20 Sep 2005 (estimated)
Study startJun 2005
Primary completionDec 2006
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Chronic, Non-malignant 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 431 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00195728
Sponsor's protocol ID: M03-666
Status last verified: Jan 2011
First submitted: 13 Sep 2005
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: An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain
ClinicalTrials.gov ID: NCT00195728
Acronym / sponsor ID: M03-666
Conditions: Moderate to Severe Chronic, Non-malignant Pain
Keywords: Hydrocodone/Acetaminophen, Vicodin CR
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 431 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Dec 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 20 Sep 2005 (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 the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
hydrocodone/acetaminophen extended release	Experimental	Drug: Hydrocodone/Acetaminophen on Extended Release

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 and Females between 21 and 75 years of age
Moderate to severe mechanical low back pain OR moderate to severe OA of the hip or knee pain
Require medicine for pain the majority of days in the previous 3 months, AND for at least 4 days per week, during the previous 4 weeks.
Pain is not controlled with non-opioid analgesics or is contraindicated due to side effects and/or currently receiving opioid therapy equivalent to 40 mg/day of morphine or less

Key exclusion criteria (36 listed)

Pregnant and/or breastfeeding females or females planning to become pregnant during the course of the study
Incapacitated, bedridden, or confined to a wheelchair permitting little or no self-care
Injury to the index joint or lower back within 3 months of study
History of any of the following:
Osteoporotic compression fracture, traumatic vertebral fracture or invasive intervention for low back pain within the last year.

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 on Extended ReleaseAlso: ABT-7122 tablets twice daily	Drug	hydrocodone/acetaminophen extended release

Primary outcome

Safety evaluation
Time frame: 56 weeks
Long term safety

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.

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

76 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydrocodone/Acetaminophen on Extended Release in people with Moderate to Severe Chronic, Non-malignant Pain, run by Abbott at 76 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 5 inclusion and 36 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 76 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Safety evaluation (time frame: 56 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00195728.

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.