Chronic PainPhase 3NCT01115569
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
A Phase 3 study testing Hydrocodone Bitartrate in people with Chronic Pain, run by Zogenix, Inc. at 50 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Hydrocodone Bitartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 50 sitesUnited States
- Study dates
- May 2010to Jan 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Blair Medical Associates
Altoona, Pennsylvania, 16602
Pain Institute of California
Bakersfield, California, 93311
Northwest Clinical Research Center
Bellevue, Washington, 98007
Nautical Clinical Research, LLC
Boise, Idaho, 83702
Suburban Clinical Research
Bolingbrook, Illinois, 60490
Providence Clinical Research
Burbank, California, 91505
Valley Medical Group, PC
Centerville, Ohio, 45459
West Side Medical
Clinton, Utah, 84015
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, 02920
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, 75235
Best Clinical Research
Decatur, Georgia, 30034
New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, 02720
The Clinical Research Center, LLC
Fort Worth, Texas, 76104
Prestige Clinical Research
Franklin, Ohio, 45005
Mountain View Clinical Research, Inc.
Golden, Colorado, 80401
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Heights Doctors Clinic
Houston, Texas, 77008
Clinical Trial Network
Houston, Texas, 77074
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Research West, LLC
Kalispell, Montana, 59901
South Orange County Surgical Medical Group
Laguna Hills, California, 92653
International Clinical Research Institute, Inc.
Leawood, Kansas, 66211
Ortho Research
Little Rock, Arkansas, 72205
Clinical Trials Managements, LLC
Mandeville, Louisiana, 70471
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
New York University Pain Management Center
New York, New York, 10016
Better Health Clinical Research, Inc
Newnan, Georgia, 30265
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747
Hillcrest Clinical Research, Inc.
Oklahoma City, Oklahoma, 73119
Memorial Clinical Research DBA Angelique Barreto, MD
Oklahoma City, Oklahoma, 73134
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Arizona Research Center
Phoenix, Arizona, 85023
HOPE Research Institute, LLC
Phoenix, Arizona, 85050
Gold Coast Research, LLC
Plantation, Florida, 33317
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206
Jean Brown Research
Salt Lake City, Utah, 84124
Quality Research, Inc.
San Antonio, Texas, 78209
Scripps Clinic, Clinical Research
San Diego, California, 92128
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101
Cochise Clinical Research
Sierra Vista, Arizona, 85635
Mid-South Anesthesia Consultants
Southaven, Mississippi, 38671
Clinvest
Springfield, Missouri, 65807
Hometown Urgent Care and Research
Springfield, Ohio, 45504
Mercy Health Research
St Louis, Missouri, 63141
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Advanced Research Institute, Inc.
Trinity, Florida, 34655
Advanced Pain Management
Virginia Beach, Virginia, 23454
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
National Pain Research Institute, Inc.
Winter Park, Florida, 32789
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Hydrocodone Bitartrate
- Keywords
- chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone BitartrateDrug
Also called Hydrocodone Bitartrate Controlled Release (HC-CR)
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
| Study group | Role | What they receive |
|---|---|---|
| Hydrocodone Bitartrate | Experimental | Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen. Receives: Drug: Hydrocodone Bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Average Daily Pain
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.
Measured: 1 year
Secondary outcomes (1)
Maintenance of Efficacy
Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
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 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vickie Gorgone, Study director, Zogenix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115569
- Sponsor's protocol ID
- ZX002-0802
- Status last verified
- Mar 2014
- First submitted
- 30 Apr 2010
- Last updated
- 9 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01115569
- Acronym / sponsor ID
- ZX002-0802
- Conditions
- Chronic Pain
- Keywords
- chronic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrocodone Bitartrate | Experimental | Drug: Hydrocodone BitartrateOpen-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 BitartrateAlso: Hydrocodone Bitartrate Controlled Release (HC-CR)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 | Drug | Hydrocodone Bitartrate |
Primary outcome
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 secondary outcome
Maintenance of Efficacy
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Pain
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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.
Vickie Gorgone study director
Zogenix, Inc.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocodone Bitartrate in people with Chronic Pain, run by Zogenix, Inc. at 50 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 6 inclusion and 7 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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 25 Apr 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 Change in Average Daily Pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.