Chronic Low Back PainPhase 3NCT00763321

Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

A Phase 3 study testing ABT-712 in people with Chronic Low Back Pain, run by AbbVie (prior sponsor, Abbott) at 31 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 primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP). 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?: ABT-712
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 287 participants
Where: 31 sitesUnited States
Study dates: Sep 2008to Apr 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adult male and female subjects who voluntarily sign the informed consent
Diagnosis of CLBP of 6 months duration

Who cannot join

Incapacitated or bedridden subjects
Subjects with history of surgical or invasive intervention

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Site Reference ID/Investigator# 10052
Altoona, Pennsylvania, 16602
Site Reference ID/Investigator# 10054
Atlanta, Georgia, 30327
Site Reference ID/Investigator# 10060
Atlantis, Florida, 33462
Site Reference ID/Investigator# 10046
Austin, Texas, 78705
Site Reference ID/Investigator# 10058
Austin, Texas, 78756
Site Reference ID/Investigator# 10062
Biloxi, Mississippi, 39531
Site Reference ID/Investigator# 10042
Bridgeville, Pennsylvania, 15017
Site Reference ID/Investigator# 10070
Burbank, California, 91505
Site Reference ID/Investigator# 10048
Chesapeake, Virginia, 23320
Site Reference ID/Investigator# 13604
Chicago, Illinois, 60654
Site Reference ID/Investigator# 10059
Dallas, Texas, 75230
Site Reference ID/Investigator# 10053
Evansville, Indiana, 47714
Site Reference ID/Investigator# 10067
Fargo, North Dakota, 58104
Site Reference ID/Investigator# 10066
Florissant, Missouri, 63031
Site Reference ID/Investigator# 10063
Greer, South Carolina, 29650
Site Reference ID/Investigator# 10069
Hollywood, Florida, 33023
Site Reference ID/Investigator# 10044
Huntsville, Alabama, 35801
Site Reference ID/Investigator# 10045
Kissimmee, Florida, 347411
Site Reference ID/Investigator# 10071
Marietta, Georgia, 30060
Site Reference ID/Investigator# 10055
Newburgh, Indiana, 47630
Site Reference ID/Investigator# 10047
Oklahoma City, Oklahoma, 73103
Site Reference ID/Investigator# 10056
Omaha, Nebraska, 68134
Site Reference ID/Investigator# 10041
Pasadena, Maryland, 21122
Site Reference ID/Investigator# 10072
Prairie Village, Kansas, 66206
Site Reference ID/Investigator# 10050
San Diego, California, 92108
Site Reference ID/Investigator# 10049
Springfield, Massachusetts, 01103
Site Reference ID/Investigator# 10073
St Louis, Missouri, 63141
Site Reference ID/Investigator# 10061
Tampa, Florida, 33603
Site Reference ID/Investigator# 10043
Valparaiso, Indiana, 46383
Site Reference ID/Investigator# 10075
Williamsville, New York, 14221
Site Reference ID/Investigator# 10065
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 of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain

Read the detailed description

The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Conditions: Chronic Low Back Pain
Being tested: ABT-712, Placebo
Keywords: Effect on sleep interference by pain

What participants receive

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

ABT-712Drug
Also called Hydrocodone and acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-release
ABT-712 extended-release tablet
PlaceboDrug
Placebo tablet

Study groups in NCT00763321
Study group	Role	What they receive
Open-label ABT-712	Experimental	2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). Receives: Drug: ABT-712
Double-blind ABT-712	Experimental	2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). Receives: Drug: ABT-712
Double-blind Placebo	Placebo comparator	2 placebo tablets, twice daily, for 4 weeks (double-blind period). Receives: Drug: Placebo

What is being measured

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

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Measured: Double-blind baseline to 4 weeks

Secondary outcomes (1)

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Measured: Double-blind baseline to 4 weeks

Timeline

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

Sep 2008Apr 2009

First posted30 Sep 2008 (estimated)
Study startSep 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763321
Sponsor's protocol ID: M10-277
Status last verified: Jan 2014
First submitted: 26 Sep 2008
Last updated: 6 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
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 6 Feb 2014. 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 of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT00763321
Acronym / sponsor ID: M10-277
Conditions: Chronic Low Back Pain
Keywords: Effect on sleep interference by pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 23 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Open-label ABT-712	Experimental	Drug: ABT-7122 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
Double-blind ABT-712	Experimental	Drug: ABT-7122 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
Double-blind Placebo	Placebo comparator	Drug: Placebo2 placebo tablets, twice daily, for 4 weeks (double-blind period).

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult male and female subjects who voluntarily sign the informed consent
Diagnosis of CLBP of 6 months duration

Key exclusion criteria (2 listed)

Incapacitated or bedridden subjects
Subjects with history of surgical or invasive intervention

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
ABT-712Also: Hydrocodone and acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-releaseABT-712 extended-release tablet	Drug	Double-blind ABT-712, Open-label ABT-712
PlaceboPlacebo tablet	Drug	Double-blind Placebo

Primary outcome

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
Time frame: Double-blind baseline to 4 weeks
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.

1 secondary outcome

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Time frame: Double-blind baseline to 4 weeks

Results and safety

Results posted to the registry on 23 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label ABT-712	285	222
Double-blind ABT-712	0	0
Double-blind Placebo	0	0

Primary outcome: Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

Time frame: Double-blind baseline to 4 weeks. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Double-blind ABT-712 n = 109	Double-blind Placebo n = 112
Value	1.2 (2.57)	23.0 (2.54)

Population analysed: The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were recorded from the time of study drug administration to 30 days after last dose (total 12 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 16 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label ABT-712	1 of 285 (0.4%)	146 of 285 (51.2%)	Not reported
Double-blind ABT-712	1 of 109 (0.9%)	31 of 109 (28.4%)	Not reported
Double-blind Placebo	1 of 113 (0.9%)	16 of 113 (14.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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.

Pedro Quintana Diez, MD study director

AbbVie

31 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 ABT-712 in people with Chronic Low Back Pain, run by AbbVie (prior sponsor, Abbott) at 31 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 2 inclusion and 2 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) (time frame: Double-blind baseline to 4 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 NCT00763321.

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 6 Feb 2014.