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Chronic Low Back PainPhase 3NCT01452529

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

A Phase 3 study testing Hydrocodone bitartrate q24h film-coated tablets in people with Chronic Low Back Pain, run by Purdue Pharma LP at 102 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 objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Hydrocodone bitartrate q24h film-coated tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
905 participants
Where
102 sitesUnited States
Study dates
Oct 2011to Oct 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
  • Subjects whose low back pain is not adequately treated prior to the screening visit with their stable incoming analgesic regimen;
  • Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to be appropriate candidates for the protocol specified, around the clock HYD therapeutic regimen;
  • Female subjects who are premenopausal or postmenopausal less than 1 year and who have not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (eg, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception).

Who cannot join

  • Subjects taking > 100 mg/day oxycodone or equivalent during last 14 days prior to screening visit;
  • Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain, excluding herbal and nutraceutical medications;
  • Subjects who cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, botulinum toxin injections for control of chronic low back pain, steroid injections in the lower back or inhalation analgesia). The subject must not have had a nerve/plexus block within 4 weeks of the screening visit, neuroablation within 6 months of the screening visit, a botulinum toxin injection in the low back region within 3 months of the screening visit, steroid injections in the lower back within 6 weeks of the screening visit, or intravenous or intramuscular steroid injections within 4 weeks of the screening visit;
  • Subjects who have used any investigational medication within 30 days prior to the first dose of study medication;
  • Subjects with any history of seizures (subjects with history of pediatric febrile seizures may participate in the study) or increase in intracranial pressure;
  • Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on a stable medication for ≥ 1 month prior to the screening visit to participate in the study);
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  • Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;
  • Subjects with clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker;
  • Subjects with unstable respiratory disease that, in the opinion of the investigator, precludes entry into this study;
  • Subjects with evidence of impaired liver function upon entry into the study (laboratory test values ≥ 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT], or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study;
  • Subjects with evidence of impaired kidney function upon entry into the study (ie, serum creatinine ≥ 2.5 mg/dL);
  • Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that, in the opinion of the investigator, is inadequately treated and precludes entry into the study;
  • Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or scheduled for surgery of the lower back or any other major surgery during the study conduct period;
  • Subjects with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
  • Subjects with any condition in which opioids are contraindicated, eg, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;
  • Subjects who are allergic to hydrocodone or who have a history of allergies to other opioids. This does not include subjects who have experienced common opioid side effects (eg, nausea, constipation);
  • Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within 2 weeks of the screening visit.
  • Other protocol-specific inclusion/exclusion criteria may apply.

Trial locations and contacts

102 sites in 1 country.

102 sites in 1 country

United States102 sites

  • Daystar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Allegheny Pain Management, P.C.

    Altoona, Pennsylvania, 16602

  • ACRI-Phase 1, LLC

    Anaheim, California, 92801-2417

  • Orange County Research Institute

    Anaheim, California, 92801

  • United Clinical Research Center, Inc.

    Anaheim, California, 92804

  • Hartwell Research Group

    Anderson, South Carolina, 29621

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • QUEST Research Institute

    Bingham Farms, Michigan, 48025

  • Alliance Clinical Research

    Birmingham, Alabama, 35213

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33472

  • Meridien Research

    Bradenton, Florida, 34208

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • Illinois Center for Clinical Research

    Chicago, Illinois, 60622

  • IVA Research

    Cincinnati, Ohio, 45245

  • Community Research

    Cincinnati, Ohio, 45255

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Community Research

    Crestview Hills, Kentucky, 41017

  • KRK Medical Research

    Dallas, Texas, 75230

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Washington Center for Pain Management

    Edmonds, Washington, 98026

  • Florida Health Center

    Fort Lauderdale, Florida, 33312

  • Clinical Physiology Associates

    Fort Myers, Florida, 33916

  • Research Center of Fresno, Inc.

    Fresno, California, 93726

  • Radiant Research, Inc.

    Greer, South Carolina, 29651

  • Drug Trials America

    Hartsdale, New York, 10530

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Comprehensive Pain Specialists, LLC

    Hendersonville, Tennessee, 37075

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Heights Doctor's Clinic

    Houston, Texas, 77008

  • Rehabilitation Associates of Indiana

    Indianapolis, Indiana, 46250

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • TriWest Research Associates

    La Mesa, California, 91942

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Research Facility

    Las Vegas, Nevada, 89144

  • Fidelity Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Skyline Research, LLC

    Long Beach, California, 90806

  • Commonwealth Biomedical Research, LLC

    Madisonville, Kentucky, 42431

  • Georgia Institute for Clinical Research, LLC

    Marietta, Georgia, 30060

  • Taylor Research, LLC

    Marietta, Georgia, 30060

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Neuroscience Consultants LLC

    Miami, Florida, 33176

  • International Research Associates, LLC

    Miami, Florida, 33183

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • Heartland Medical, PC

    New Tazewell, Tennessee, 37825

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Better Health Clinical Research, Inc.

    Newnan, Georgia, 30265

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Journey Research, Inc

    Oldsmar, Florida, 34677

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Peninsula Research Inc.

    Ormond Beach, Florida, 32174

  • ICRI

    Overland Park, Kansas, 66210

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania, 19139

  • Founders Research Corporation

    Philadelphia, Pennsylvania, 19152

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Redpoint Research

    Phoenix, Arizona, 85029

  • Advent Clinical Research Centers, Inc.

    Pinellas Park, Florida, 33781

  • Gold Coast Research, LLC

    Plantation, Florida, 33317

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Center for Clinical Research, Inc.

    Richmond, California, 94806

  • HypotheTest, LLC

    Roanoke, Virginia, 24018

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Northern California Research

    Sacramento, California, 95821

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Sarasota Research, LLC

    Sarasota, Florida, 34243

  • HCCA Clinical Research Solutions

    Smyrna, Tennessee, 37167

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Advance Clinical Research

    St Louis, Missouri, 63128

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Atlanta Knee and Shoulder Clinic, PC

    Stockbridge, Georgia, 30281

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • Tipton Medical & Diagnostic Center

    Tipton, Pennsylvania, 16684

  • Bone Joint and Spine Surgeons, Inc.

    Toledo, Ohio, 43623

  • IRC Clinics, Inc.

    Towson, Maryland, 21204

  • Medical Research Associates, Inc.

    Traverse City, Michigan, 49684

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Redpoint Research

    Tucson, Arizona, 85712

  • Northwest Indiana Center for Clinical Research

    Valparaiso, Indiana, 46383

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472-3930

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • CRI Worldwide LLC

    Willingboro, New Jersey, 08046

  • PMG Research of Wilmington LLC

    Wilmington, North Carolina, 28401

  • Clinical Trials of America, Inc.

    Winston-Salem, North Carolina, 27103

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain

The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Being tested
Hydrocodone bitartrate q24h film-coated tablets, Placebo to match hydrocodone bitartrate q24h tablets
Keywords
Pain, Opioid
Medical subject headings
Pain

What participants receive

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

  • Hydrocodone bitartrate q24h film-coated tabletsDrug

    Also called Hysingla ER

    Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

  • Placebo to match hydrocodone bitartrate q24h tabletsDrug

    Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Study groups in NCT01452529
Study groupRoleWhat they receive
Hydrocodone bitartrateExperimentalHydrocodone bitartrate (HYD) once daily (q24h) tablets
Receives: Drug: Hydrocodone bitartrate q24h film-coated tablets
PlaceboPlacebo comparatorPlacebo to match hydrocodone bitartrate once daily tablets
Receives: Drug: Placebo to match hydrocodone bitartrate q24h tablets

What is being measured

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

  1. Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score

    Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).

    Measured: Week 12

Secondary outcomes (4)

  1. Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale

    The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern.

    Measured: Weeks 4, 8, and 12

  2. Patient Global Impression of Change (PGIC)

    The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "very much improved" and "much improved" was summarized by treatment group.

    Measured: Week 12

  3. Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline

    A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.

    Measured: Baseline to Week 12

  4. Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline

    A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.

    Measured: Baseline to Week 12

Timeline

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

  1. First posted17 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2013
  4. Study completionOct 2013

Resources

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
Who is masked
Participant, Investigator
Enrolment
905 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452529
Sponsor's protocol ID
HYD3002
Status last verified
Mar 2020
First submitted
12 Oct 2011
Last updated
10 Mar 2020
Data monitoring committee
Yes

Publications

  • Wen W, Sitar S, Lynch SY, He E, Ripa SR. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain. Expert Opin Pharmacother. 2015;16(11):1593-606. doi: 10.1517/14656566.2015.1060221. Epub 2015 Jun 26.

    PubMed 26111544

  • Campbell K, Kutz JW Jr, Shoup A, Wen W, Lynch SY, He E, Ripa SR. Evaluation of the Ototoxicity Potential of Once-Daily, Single-Entity Hydrocodone in Patients with Chronic Pain: Results of Two Phase-3 Clinical Studies. Pain Physician. 2017 Jan-Feb;20(1):E183-E193.

    PubMed 28072811

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydrocodone bitartrate q24h film-coated tablets in people with Chronic Low Back Pain, run by Purdue Pharma LP at 102 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 4 inclusion and 18 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 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 4 Dec 2014). 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?

Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score (time frame: Week 12). 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 NCT01452529, which also lists 2 linked publications.

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 10 Mar 2020.

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