Chronic Low Back PainPhase 2NCT01364922

Phase 2 Chronic Low Back Pain Study

A Phase 2 study testing hydrocodone/acetaminophen extended release in people with Chronic Low Back Pain, run by AbbVie (prior sponsor, Abbott) at 17 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

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: hydrocodone/acetaminophen extended release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 17 sitesUnited States
Study dates: Jun 2011to Oct 2011
Phase: Phase 2
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

Who cannot join

Subjects with a history of surgical or invasive intervention

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Site Reference ID/Investigator# 54876
Anaheim, California, 92801
Site Reference ID/Investigator# 54877
Burbank, California, 91505
Site Reference ID/Investigator# 54872
Cincinnati, Ohio, 45227
Site Reference ID/Investigator# 54874
DeLand, Florida, 32720
Site Reference ID/Investigator# 54745
Killeen, Texas, 76543
Site Reference ID/Investigator# 54873
Lomita, California, 90717
Site Reference ID/Investigator# 54879
Marietta, Georgia, 30060
Site Reference ID/Investigator# 54863
Marion, Ohio, 43302
Site Reference ID/Investigator# 54866
Oldsmar, Florida, 34677
Site Reference ID/Investigator# 54862
Pasadena, Maryland, 21122
Site Reference ID/Investigator# 54782
Prairie Village, Kansas, 66206
Site Reference ID/Investigator# 54742
San Antonio, Texas, 78209-1744
Site Reference ID/Investigator# 54880
St Louis, Missouri, 63141
Site Reference ID/Investigator# 54875
Tucson, Arizona, 85704
Site Reference ID/Investigator# 54865
Valparaiso, Indiana, 46383
Site Reference ID/Investigator# 54878
Watertown, Massachusetts, 02472-3930
Site Reference ID/Investigator# 54881
Williamsville, New York, 14221

Other trials in United States

About this study

Official title: A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Read the detailed description

This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Conditions: Chronic Low Back Pain
Being tested: hydrocodone/acetaminophen extended release, Placebo

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 ABT-712
PlaceboDrug

Study groups in NCT01364922
Study group	Role	What they receive
Open-label Hydrocodone/Acetaminophen Extended Release	Experimental	Hydrocodone/acetaminophen extended release, 2 tablets twice daily Receives: Drug: hydrocodone/acetaminophen extended release
Double-blind Hydrocodone/Acetaminophen Extended Release	Experimental	Hydrocodone/acetaminophen extended release, 1 tablet twice daily Receives: Drug: hydrocodone/acetaminophen extended release
Double-blind Placebo	Placebo comparator	Placebo, 1 tablet twice daily Receives: Drug: Placebo

What is being measured

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

Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind 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 an ANCOVA model.
Measured: Double-blind baseline to Day 29

Secondary outcomes (2)

Participant's Global Assessment of Back Pain Status at Final Evaluation
The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Measured: Double-blind baseline to Day 29
Participant's Global Assessment of Study Drug at Final Evaluation
The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor.
Measured: Double-blind baseline to Day 29

Timeline

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

Jun 2011Oct 2011

First posted3 Jun 2011 (estimated)
Study startJun 2011
Primary completionOct 2011
Study completionOct 2011

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01364922
Sponsor's protocol ID: M12-807
Status last verified: Dec 2013
First submitted: 1 Jun 2011
Last updated: 29 Jan 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

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PRP Versus NP Injections for Chronic Discogenic Low Back Pain
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Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
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Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
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Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
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Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01364922
Acronym / sponsor ID: M12-807
Conditions: Chronic Low Back Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 3 Jun 2011 (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.

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Open-label Hydrocodone/Acetaminophen Extended Release	Experimental	Drug: hydrocodone/acetaminophen extended releaseHydrocodone/acetaminophen extended release, 2 tablets twice daily
Double-blind Hydrocodone/Acetaminophen Extended Release	Experimental	Drug: hydrocodone/acetaminophen extended releaseHydrocodone/acetaminophen extended release, 1 tablet twice daily
Double-blind Placebo	Placebo comparator	Drug: PlaceboPlacebo, 1 tablet twice daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

Key exclusion criteria (1 listed)

Subjects with a 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
hydrocodone/acetaminophen extended releaseAlso: ABT-712	Drug	Double-blind Hydrocodone/Acetaminophen Extended Release, Open-label Hydrocodone/Acetaminophen Extended Release
Placebo	Drug	Double-blind Placebo

Primary outcome

Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
Time frame: Double-blind baseline to Day 29
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind 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 an ANCOVA model.

2 secondary outcomes

Participant's Global Assessment of Back Pain Status at Final Evaluation
Time frame: Double-blind baseline to Day 29
Participant's Global Assessment of Study Drug at Final Evaluation
Time frame: Double-blind baseline to Day 29

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 Hydrocodone/Acetaminophen Extended Release	168	146
Double-blind Hydrocodone/Acetaminophen Extended Release	0	0
Double-blind Placebo	0	0

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

Time frame: Double-blind baseline to Day 29. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Double-blind Hydrocodone/Acetaminophen Extended Release n = 95	Double-blind Placebo n = 46
Value	10.9 (2.86)	19.9 (3.77)

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) and had at least 1 assessment during the double-blind period.

2 secondary outcomes are 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 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label Hydrocodone/Acetaminophen Extended Release	0 of 168 (0%)	70 of 168 (41.7%)	Not reported
Double-blind Hydrocodone/Acetaminophen Extended Release	0 of 99 (0%)	7 of 99 (7.1%)	Not reported
Double-blind Placebo	1 of 47 (2.1%)	8 of 47 (17%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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 recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hydrocodone/acetaminophen extended release in people with Chronic Low Back Pain, run by AbbVie (prior sponsor, Abbott) at 17 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 1 inclusion and 1 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 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?

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 Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) (time frame: Double-blind baseline to Day 29). 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 NCT01364922.

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 29 Jan 2014.