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Chronic Nonmalignant and Nonneuropathic PainPhase 3NCT01400139

Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.

A Phase 3 study testing Hydrocodone bitartrate q24h film-coated tablets in people with Chronic Nonmalignant and Nonneuropathic Pain, run by Purdue Pharma LP at 98 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 characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hydrocodone bitartrate q24h film-coated tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
922 participants
Where
98 sitesUnited States
Study dates
Jul 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 nonmalignant and nonneuropathic pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
  • 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);
  • Subjects who are willing and able to be compliant with the protocol, are capable of subjective evaluation (ie pain scores), are able to read and understand questionnaires, are willing and able to use an electronic diary, and are able to read, understand, and sign the written informed consent form in English.

Who cannot join

  • Subjects taking opioid analgesic(s) equivalent to > 120 mg/day of oxycodone during the 14 days prior to the screening visit;
  • Subjects who previously participated in an investigational hydrocodone study within 90 days prior to the first dose of study medication ;
  • Subjects who have used any investigational medication other than hydrocodone within 30 days prior to the first dose of study drug;
  • 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);
  • Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;
Show all 16Show fewer
  • 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 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 with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
  • 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 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

98 sites in 1 country.

98 sites in 1 country

United States98 sites

  • Daystar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Allegheny Pain Management, P.C.

    Altoona, Pennsylvania, 16602

  • ACRI -Phase1, LLC

    Anaheim, California, 92801-2417

  • United Clinical Research Center, Inc.

    Anaheim, California, 92804

  • Hartwell Research Group

    Anderson, South Carolina, 29621

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Lovelace Scientific Resources, Inc.

    Austin, Texas, 78758

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Pennsylvania Research Institute

    Bensalem, Pennsylvania, 19020

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Alliance Clinical Research

    Birmingham, Alabama, 35213

  • Meridien Research

    Bradenton, Florida, 34208

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Med Center

    Carmichael, California, 95608

  • Pain Research of Charleston

    Charleston, South Carolina, 29406

  • 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

  • Clinical Physiology Associates

    Fort Myers, Florida, 33916

  • Research Center of Fresno, Inc.

    Fresno, California, 93726

  • Radiant Research, Inc.

    Greer, South Carolina, 29651

  • MD Clinical

    Hallandale, Florida, 33009

  • Drug Trials America

    Hartsdale, New York, 10530

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Heights Doctor's Clinic

    Houston, Texas, 77008

  • JVC Family Medicine

    Houston, Texas, 77040

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77098

  • Rehabilitation Associates of Indiana

    Indianapolis, Indiana, 46250

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • TEAM Research of Central Texas

    Killeen, Texas, 76543

  • 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

  • ICRI

    Leawood, Kansas, 66211

  • Torrance Clinical Research

    Lomita, California, 90717

  • Skyline Research, LLC

    Long Beach, California, 90806

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • 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

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • Heartland Medical, PC

    New Tazewell, Tennessee, 37825

  • Research Across America

    New York, New York, 10022

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Lotus Clinical Research, LLC

    Pasadena, California, 91105

  • CRI Worldwide LLC

    Philadelphia, Pennsylvania, 19139

  • Founders Research Corporation

    Philadelphia, Pennsylvania, 19152

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • 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

  • 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

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Medical Research Associates, Inc.

    Traverse City, Michigan, 49684

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Quality of Life Medical & Research Center, LLC

    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: An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain

The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.

Being tested
Hydrocodone bitartrate q24h film-coated tablets
Keywords
Pain, Nonmalignant pain, Nonneuropathic 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

Study groups in NCT01400139
Study groupRoleWhat they receive
Hydrocodone bitartrateExperimentalHydrocodone bitartrate (HYD) once daily (q24h) tablets
Receives: Drug: Hydrocodone bitartrate q24h film-coated tablets

What is being measured

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

  1. The Number of Participants With Adverse Events as a Measure of Safety

    Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.

    Measured: Up to 84 weeks

  2. Daily "Average Pain Over the Last 24 Hours"

    "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: Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)

Secondary outcomes (7)

  1. "Pain Right Now" Score

    "Pain right now" scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The "pain right now" scores were only collected during the Core Study. "Pain right now" scores were not assessed during the Extension Period.

    Measured: Week 12

  2. Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)

    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 II and 6 subscale scores - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For each individual and time of assessment, quantity of sleep was recorded as the number of hours slept per night. The number of hours it took the subject to fall asleep per night was categorized 1, 2, 3, 4, or 5 corresponding to 0 through 15, 16 through 30, 31 through 45, 46 through 60, or more than 60 minutes, respectively. The other scales were recorded as 1 = all of the time, 2 = most of the time, 3 = some of the time, 4 = a little of the time, or 5 = none of the time. A higher value indicates a better score, therefore a positive change from baseline indicates a better sleep pattern and a negative change from baseline indicates a worsening in sleep pattern.

    Measured: Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period

  3. Brief Pain Inventory Short Form (BPI-SF)

    The BPI-SF assessed the severity of pain and interference of pain on daily functions. It consists of 9 sections denoted by Q1 to Q8 and Q9A to Q9G according to their order in the questionnaire, that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Scores ranged from 0 (none) to 10 (worst as can be). Four of the items (questions 3 to 6) assess severity of pain and 7 items (questions 9A to 9G) assess interference of pain. The pain interference subscale score was determined by calculating the mean of responses to Q9A - Q9G [Q9A (general activity), Q9B (mood),Q9C (walking), Q9D (working), Q9E (relations with others), Q9F (sleep), and Q9G (enjoyment of life)] and the severity of pain subscale score was determined by calculating the mean of responses to Q3 - Q6 [Q3 (worst pain in last 24 hours), Q4 (least pain in last 24 hours), Q5 (average pain), and Q6 ("pain right now")]. A lower score indicates lower pain.

    Measured: Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period

  4. Medical Outcomes Study 36-item Short Form (SF-36)

    The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. Scores on each scale ranged from 0 to 100; a higher score indicates a better perception of health.

    Measured: Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period

  5. Patient Global Impression of Change (PGIC)

    The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse.

    Measured: At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period

  6. Treatment Satisfaction Questionnaire (TSQ) - Part I

    The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. The number of subjects with each category (1-6) of response for each individual question (Q1-Q6) was summarized for subjects who entered the core study maintenance period and responded to each question. TSQ - Part I was not administered in the extension period.

    Measured: At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period

  7. Treatment Satisfaction Questionnaire (TSQ) - Part II

    The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided. The number of subjects with each category of response for each individual question was summarized for subjects completing the core study maintenance period and for those enrolled in the extension period.

    Measured: At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension

Timeline

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

  1. First posted22 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionAug 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01400139
Sponsor's protocol ID
HYD3003
Status last verified
Mar 2020
First submitted
20 Jul 2011
Last updated
10 Mar 2020
Data monitoring committee
Yes

Publications

  • Wen W, Taber L, Lynch SY, He E, Ripa S. 12-Month safety and effectiveness of once-daily hydrocodone tablets formulated with abuse-deterrent properties in patients with moderate to severe chronic pain. J Opioid Manag. 2015 Jul-Aug;11(4):339-56. doi: 10.5055/jom.2015.0283.

    PubMed 26312961

  • 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

  • Kapil RP, Cipriano A, Wen W, Yu Lynch S, He E, Colucci SV, Harris SC. Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties. Clin Ther. 2016 Feb;38(2):302-14. doi: 10.1016/j.clinthera.2015.12.003. Epub 2015 Dec 31.

    PubMed 26749219

  • Taber L, Lynch SY, He E, Ripa SR. Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain. Postgrad Med. 2016 Jan;128(1):23-33. doi: 10.1080/00325481.2016.1134022. Epub 2016 Jan 12.

    PubMed 26681111

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 Nonmalignant and Nonneuropathic Pain, run by Purdue Pharma LP at 98 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 16 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 98 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. 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?

The Number of Participants With Adverse Events as a Measure of Safety (time frame: Up to 84 weeks). The study lists 2 primary outcomes in all. 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 NCT01400139, which also lists 4 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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