MedDataX Logo

Phase 2 Chronic Low Back Pain Study

NCT ID: NCT01364922

Last Updated: 2014-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Pain Relief in Low Back Pain

NCT00325949

Chronic Low Back Pain
COMPLETED PHASE3

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

NCT00761150

Chronic Low Back Pain
COMPLETED PHASE3

Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

NCT01081912

Back Pain Lower Back Chronic
COMPLETED PHASE3

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

NCT00763321

Chronic Low Back Pain
COMPLETED PHASE3

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

NCT01789970

Low Back Pain
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open-label Hydrocodone/Acetaminophen Extended Release

Hydrocodone/acetaminophen extended release, 2 tablets twice daily

Group Type EXPERIMENTAL

hydrocodone/acetaminophen extended release

Intervention Type DRUG

Double-blind Hydrocodone/Acetaminophen Extended Release

Hydrocodone/acetaminophen extended release, 1 tablet twice daily

Group Type EXPERIMENTAL

hydrocodone/acetaminophen extended release

Intervention Type DRUG

Double-blind Placebo

Placebo, 1 tablet twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hydrocodone/acetaminophen extended release

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-712

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

Subjects with a history of surgical or invasive intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pedro Quintana Diez, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 54875

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 54876

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 54877

Burbank, California, United States

Site Status

Site Reference ID/Investigator# 54873

Lomita, California, United States

Site Status

Site Reference ID/Investigator# 54874

DeLand, Florida, United States

Site Status

Site Reference ID/Investigator# 54866

Oldsmar, Florida, United States

Site Status

Site Reference ID/Investigator# 54879

Marietta, Georgia, United States

Site Status

Site Reference ID/Investigator# 54865

Valparaiso, Indiana, United States

Site Status

Site Reference ID/Investigator# 54782

Prairie Village, Kansas, United States

Site Status

Site Reference ID/Investigator# 54862

Pasadena, Maryland, United States

Site Status

Site Reference ID/Investigator# 54878

Watertown, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 54880

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 54881

Williamsville, New York, United States

Site Status

Site Reference ID/Investigator# 54872

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 54863

Marion, Ohio, United States

Site Status

Site Reference ID/Investigator# 54745

Killeen, Texas, United States

Site Status

Site Reference ID/Investigator# 54742

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://rxabbvie.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M12-807

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
NCT01452529 COMPLETED PHASE3
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
NCT02367820 COMPLETED PHASE3
Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)
NCT03201393 COMPLETED PHASE2
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
NCT01922739 COMPLETED PHASE3
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
NCT02716857 COMPLETED PHASE3
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
NCT00449176 COMPLETED PHASE3
Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
NCT00195728 COMPLETED PHASE3
Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.
NCT01838616 COMPLETED PHASE4
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
NCT01685684 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
NCT01240863 COMPLETED PHASE3
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
NCT00983385 COMPLETED PHASE3
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
NCT00986258 TERMINATED PHASE3
An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)
NCT01631513 WITHDRAWN PHASE4
Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain
NCT01344720 UNKNOWN PHASE4
Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
NCT00594516 COMPLETED PHASE3
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
NCT06931158 RECRUITING NA
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
NCT01115569 COMPLETED PHASE3
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
NCT03137030 WITHDRAWN PHASE1
Optimizing Open Label Placebo Rationales
NCT05952960 COMPLETED NA
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
NCT01177280 COMPLETED
Phase 1 Pharmacokinetic Study of Tapentadol Prolonged-Release 250 Milligram (mg) Formulation in Healthy Participants
NCT01877226 COMPLETED PHASE1
Opioid Taper Study
NCT03912298 COMPLETED
Evolution of Analgesic Tolerance With Opioids
NCT00275249 COMPLETED NA
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
NCT00771758 COMPLETED PHASE3
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
NCT03137017 WITHDRAWN PHASE1