Chronic Low Back PainPhase 3NCT00325949

A Study of Pain Relief in Low Back Pain

A Phase 3 study testing Extended release hydrocodone and acetaminophen (Vicodin CR) and hydrocodone/acetaminophen extended release (Vicodin CR) in people with Chronic Low Back Pain, run by Abbott at 63 sites in United States.

Completed

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

Official record

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Trial summary

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Extended release hydrocodone and acetaminophen (Vicodin CR) and hydrocodone/acetaminophen extended release (Vicodin CR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 770 participants
Where: 63 sitesUnited States
Study dates: May 2006to Jun 2007
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, ages 21-75 years
If female, must be of non-child bearing potential or practicing birth control
Has a history of chronic low back pain for at least 6 months
Requires medication for the management of the chronic low back pain
Has sufficient pain to justify the use of around-the-clock opioids

Who cannot join

Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Cannot discontinue pain medications, even for the short time prior to the study start
Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery
Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
Has a history of malnutrition or starvation

Show all 14Show fewer

Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
Is a pregnant or breastfeeding woman
Is incapacitated, bedridden, or confined to a wheelchair
Has initiated any new therapy or medication for chronic low back pain within 1 month of screening
Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame
Has back pain due to or associated with certain types of conditions
Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

United States63 sites

Site Ref # / Investigator 1975
Atlanta, Georgia, 30328
Site Ref # / Investigator 2217
Austin, Texas, 78705
Site Ref # / Investigator 3420
Biloxi, Mississippi, 39531
Site Ref # / Investigator 2603
Brockton, Massachusetts, 02301
Site Ref # / Investigator 1992
Buena Park, California, 90620
Site Ref # / Investigator 2607
Bulverde, Texas, 78163
Site Ref # / Investigator 1993
Burbank, California, 91505
Site Ref # / Investigator 1985
Chicago, Illinois, 60610
Site Ref # / Investigator 2218
Cincinnati, Ohio, 45227
Site Ref # / Investigator 1995
Cincinnati, Ohio, 45242
Site Ref # / Investigator 1987
Cincinnati, Ohio, 45245
Site Ref # / Investigator 2208
Clearwater, Florida, 33756
Site Ref # / Investigator 1984
Cordova, Tennessee, 38018
Site Ref # / Investigator 2137
Cranston, Rhode Island, 02920
Site Ref # / Investigator 2590
Dallas, Texas, 75251
Site Ref # / Investigator 1991
Decatur, Georgia, 30033
Site Ref # / Investigator 2210
DeLand, Florida, 32720
Site Ref # / Investigator 2157
Denver, Colorado, 80209
Site Ref # / Investigator 2215
Downingtown, Pennsylvania, 19335
Site Ref # / Investigator 2579
Duncansville, Pennsylvania, 16635
Site Ref # / Investigator 1978
Evansville, Indiana, 47714
Site Ref # / Investigator 2219
Fair Oaks, California, 95628
Site Ref # / Investigator 2556
Florissant, Missouri, 63031
Site Ref # / Investigator 2221
Greer, South Carolina, 29651
Site Ref # / Investigator 2207
Hollywood, Florida, 33023
Site Ref # / Investigator 2216
Hueytown, Alabama, 35023
Site Ref # / Investigator 2117
Killeen, Texas, 76543
Site Ref # / Investigator 3421
Las Vegas, Nevada, 89106
Site Ref # / Investigator 2206
Las Vegas, Nevada, 89123
Site Ref # / Investigator 1989
Los Gatos, California, 95032
Site Ref # / Investigator 2213
Mechanicsburg, Pennsylvania, 17055
Site Ref # / Investigator 2209
Metairie, Louisiana, 70006
Site Ref # / Investigator 2204
Miami, Florida, 33156
Site Ref # / Investigator 2205
Miami, Florida, 33186
Site Ref # / Investigator 1982
Missoula, Montana, 59802
Site Ref # / Investigator 2604
Nederland, Texas, 77627
Site Ref # / Investigator 1973
New York, New York, 10022
Site Ref # / Investigator 2211
Oklahoma City, Oklahoma, 73103
Site Ref # / Investigator 2214
Oldsmar, Florida, 34677
Site Ref # / Investigator 1986
Omaha, Nebraska, 68134
Site Ref # / Investigator 2203
Pasadena, Maryland, 21122
Site Ref # / Investigator 2605
Phoenix, Arizona, 85023
Site Ref # / Investigator 1990
Phoenix, Arizona, 85029
Site Ref # / Investigator 2135
Plantation, Florida, 33324
Site Ref # / Investigator 2580
Prairie Village, Kansas, 66206
Site Ref # / Investigator 1983
Raleigh, North Carolina, 27609
Site Ref # / Investigator 2606
Raleigh, North Carolina, 27612
Site Ref # / Investigator 1979
Richardson, Texas, 75080
Site Ref # / Investigator 2212
San Angelo, Texas, 76904
Site Ref # / Investigator 1981
San Antonio, Texas, 78127
Site Ref # / Investigator 2220
San Antonio, Texas, 78209
Site Ref # / Investigator 2608
San Antonio, Texas, 78218
Site Ref # / Investigator 1976
Shreveport, Louisiana, 71103
Site Ref # / Investigator 1980
St Louis, Missouri, 63141
Site Ref # / Investigator 1974
Tempe, Arizona, 85282
Site Ref # / Investigator 1994
Trumbull, Connecticut, 06611
Site Ref # / Investigator 1977
Tucson, Arizona, 85741
Site Ref # / Investigator 2158
Virginia Beach, Virginia, 23454
Site Ref # / Investigator 2156
Wellesley Hills, Massachusetts, 02481-2106
Site Ref # / Investigator 1988
West Des Moines, Iowa, 50265
Site Ref # / Investigator 2134
West Palm Beach, Florida, 33409-3509
Site Ref # / Investigator 2578
Williamsville, New York, 14221
Site Ref # / Investigator 5161
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain

Conditions: Chronic Low Back Pain
Being tested: Extended release hydrocodone and acetaminophen (Vicodin CR), hydrocodone/acetaminophen extended release (Vicodin CR), placebo

What participants receive

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

Extended release hydrocodone and acetaminophen (Vicodin CR)Drug
Also called hydrocodone / acetaminophen extended release
2 tablets BID
hydrocodone/acetaminophen extended release (Vicodin CR)Drug
Also called hydrocodone/acetaminophen extended release
1 tablet BID
placeboDrug
2 tablets BID

Study groups in NCT00325949
Study group	Role	What they receive
arm label (1) hydrocodone/acetaminophen extended release	Experimental	Not described Receives: Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)
arm label (2) hydrocodone/acetaminophen extended release	Experimental	Not described Receives: Drug: hydrocodone/acetaminophen extended release (Vicodin CR)
Arm label (3) 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 randomization baseline to each subject's final assessment
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)
Measured: 12 Weeks

Secondary outcomes (4)

Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
Pain Intensity Difference from randomization baseline to each scheduled assessment
Global Assessments of Study Drug and Back Pain Status
Roland-Morris Disability Questionnaire

Timeline

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

May 2006Jun 2007

First posted15 May 2006 (estimated)
Study startMay 2006
Primary completionMay 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Low Back 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 770 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00325949
Sponsor's protocol ID: M05-790
Status last verified: Jul 2011
First submitted: 11 May 2006
Last updated: 25 Jul 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

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 Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT00325949
Acronym / sponsor ID: M05-790
Conditions: Chronic Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 770 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: May 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 15 May 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.

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
arm label (1) hydrocodone/acetaminophen extended release	Experimental	Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)
arm label (2) hydrocodone/acetaminophen extended release	Experimental	Drug: hydrocodone/acetaminophen extended release (Vicodin CR)
Arm label (3) 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 and females, ages 21-75 years
If female, must be of non-child bearing potential or practicing birth control
Has a history of chronic low back pain for at least 6 months
Requires medication for the management of the chronic low back pain
Has sufficient pain to justify the use of around-the-clock opioids

Key exclusion criteria (14 listed)

Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Cannot discontinue pain medications, even for the short time prior to the study start
Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery
Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract

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 and acetaminophen (Vicodin CR)Also: hydrocodone / acetaminophen extended release2 tablets BID	Drug	arm label (1) hydrocodone/acetaminophen extended release
hydrocodone/acetaminophen extended release (Vicodin CR)Also: hydrocodone/acetaminophen extended release1 tablet BID	Drug	arm label (2) hydrocodone/acetaminophen extended release
placebo2 tablets BID	Drug	Arm label (3) placebo

Primary outcome

Pain Intensity Difference from randomization baseline to each subject's final assessment
Time frame: 12 Weeks
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)

4 secondary outcomes

Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
Pain Intensity Difference from randomization baseline to each scheduled assessment
Global Assessments of Study Drug and Back Pain Status
Roland-Morris Disability Questionnaire

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.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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, M.D. study director

Abbott

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

Questions about this trial

What is this clinical trial studying?

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 14 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.

Where is the study taking place?

The record lists 63 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 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?

Pain Intensity Difference from randomization baseline to each subject's final assessment (time frame: 12 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 NCT00325949.

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.