Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

November 8, 2022 updated by: Zogenix, Inc.

A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain

This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute, LLC
      • Sierra Vista, Arizona, United States, 85635
        • Cochise Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Ortho Research
    • California
      • Bakersfield, California, United States, 93311
        • Pain Institute of California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Laguna Hills, California, United States, 92653
        • South Orange County Surgical Medical Group
      • San Diego, California, United States, 92128
        • Scripps Clinic, Clinical Research
    • Colorado
      • Golden, Colorado, United States, 80401
        • Mountain View Clinical Research, Inc.
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Jacksonville, Florida, United States, 32257
        • Florida Institute of Medical Research
      • Plantation, Florida, United States, 33317
        • Gold Coast Research, LLC
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute, Inc.
      • Winter Park, Florida, United States, 32789
        • National Pain Research Institute, Inc.
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Best Clinical Research
      • Marietta, Georgia, United States, 30060
        • Georgia Institute for Clinical Research, LLC
      • Newnan, Georgia, United States, 30265
        • Better Health Clinical Research, Inc
    • Idaho
      • Boise, Idaho, United States, 83702
        • Nautical Clinical Research, LLC
    • Illinois
      • Bolingbrook, Illinois, United States, 60490
        • Suburban Clinical Research
    • Kansas
      • Leawood, Kansas, United States, 66211
        • International Clinical Research Institute, Inc.
      • Prairie Village, Kansas, United States, 66206
        • Clinical Trials Technology, Inc.
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Managements, LLC
      • Shreveport, Louisiana, United States, 71101
        • Willis-Knighton Physician Network
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
      • North Dartmouth, Massachusetts, United States, 02747
        • Infinity Medical Research, Inc.
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Mid-South Anesthesia Consultants
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Health Research
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • Montana
      • Kalispell, Montana, United States, 59901
        • Research West, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc.
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group
      • New York, New York, United States, 10016
        • New York University Pain Management Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Valley Medical Group, PC
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Springfield, Ohio, United States, 45504
        • Hometown Urgent Care and Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73119
        • Hillcrest Clinical Research, Inc.
      • Oklahoma City, Oklahoma, United States, 73134
        • Memorial Clinical Research DBA Angelique Barreto, MD
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Medical Associates
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research, Inc.
    • Texas
      • Dallas, Texas, United States, 75235
        • Renaissance Clinical Research and Hypertension Clinic
      • Fort Worth, Texas, United States, 76104
        • The Clinical Research Center, LLC
      • Houston, Texas, United States, 77008
        • Heights Doctors Clinic
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78209
        • Quality Research, Inc.
    • Utah
      • Clinton, Utah, United States, 84015
        • West Side Medical
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Advanced Pain Management
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
  • Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
  • Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
  • Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
  • Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
  • Subjects must voluntarily provide written informed consent

Exclusion Criteria:

  • Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
  • A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug
  • A surgical procedure for pain within the last 3 months
  • Uncontrolled blood pressure, i.e., a sitting systolic blood pressure >180 mm Hg or <90 mm Hg, and/or a sitting diastolic blood pressure >120 mm Hg or <50 mm Hg at Screening
  • A body mass index (BMI) > 45 kg/m2
  • A hospital anxiety and depression scale (HADS) score of >12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
  • A clinically significant abnormality in clinical chemistry, hematology or urinalysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hydrocodone Bitartrate
Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Drug: Hydrocodone Bitartrate
Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Other Names:
  • Hydrocodone Bitartrate Controlled Release (HC-CR)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Average Daily Pain
Time Frame: 1 year
Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maintenance of Efficacy
Time Frame: 1 year
Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zogenix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vickie Gorgone, Zogenix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZX002-0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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