Back Pain Lower Back ChronicPhase 3NCT01081912
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
A Phase 3 study testing Hydrocodone bitartrate in people with Back Pain Lower Back Chronic, run by Zogenix, Inc. at 51 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Hydrocodone bitartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 51 sitesUnited States
- Study dates
- Mar 2010to Oct 2011
- 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 clinical diagnosis of moderate to severe chronic lower back pain (CLBP)
- Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery
- Subjects must in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their chronic lower back pain (CLBP).
- Subjects must have been taking opioids for at least 5 days/week for the past 4weeks
- Subjects must have an average Clinic Pain Score of ≥ 4 on the 11-point (0-10) numeric rating scale (NRS) as an average for the last 24 hours of Screening
- Subjects, in the opinion of the Investigator, must be considered to be in generally good health other then CLBP at Screening
- Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
- 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 and other symptoms of CLBP or increase the risk of opioid-related adverse events
- A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug
- A surgical procedure for back pain within 6 months
- A nerve or plexus block, including epidural steroid injections or facet blocks
- A history of chemotherapy or confirmed malignancy within past 2 years
- Any other chronic pain condition other than CLBP that, in the Investigator's opinion, would interfere with the assessment of LBP e.g. fibromyalgia, osteoarthritis, rheumatoid arthritis, migraine headaches requiring opioid treatment
Show all 10Show fewer
- Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure >180 mmHg or <90 mmHg, and/or a sitting diastolic blood pressure >120 mmHg or <50 mmHg at Screening
- A Body Mass Index (BMI) >45 kg/m2
- A Hospital Anxiety and Depression Scale (HADS) Index score of >12 in either depression or anxiety subscales or an established history of major depressive disorder that is poorly controlled with medication
- A clinically significant abnormality in clinical chemistry, hematology or urinalysis
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338
Northwest Clinical Research Center
Bellevue, Washington, 98007
Center for Clinical Trials
Biloxi, Mississippi, 39531
South Jersey Medical Associates
Blackwood, New Jersey, 08012
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513
Five Towns Neuroscience Research
Cedarhurst, New York, 11516
Suburban Clinical Research
Chicago, Illinois, 60490
IVA Research
Cincinnati, Ohio, 45245
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Clinicos, LLC
Colorado Springs, Colorado, 80904
New England Center for Clinical Research
Cranston, Rhode Island, 02920
InSite Clinical Research
DeSoto, Texas, 75115
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335
Destiny Clinical Research, LLC
Evansville, Indiana, 47714
NECCR Internal Medicine & Cardiology Associates, LLC
Fall River, Massachusetts, 02720
Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053
Prestige Clinical Research
Franklin, Ohio, 45005
Neuro-Pain Medical Center, Inc.
Fresno, California, 93710
Clinical Trial Network
Houston, Texas, 77074
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Clopton Clinic
Jonesboro, Arkansas, 72401
Research West, LLC
Kalispell, Montana, 59901
Pacific Coast Pain Management Center
Laguna Hills, California, 92637
Office of Danka Michaels, MD
Las Vegas, Nevada, 89128
International Clinical Research Institute
Leawood, Kansas, 66211
Interwest Rehabilitation, LLC
Littleton, Colorado, 80122
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
Clinical Trials Management
Metairie, Louisiana, 70006
Integrity Clinical Research, LLC
Milan, Tennessee, 38358
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
Advanced Research Institute
Ogden, Utah, 84405
Neuropsychiatric Research Center
Oklahoma City, Oklahoma, 73109
Peninsula Research, Inc.
Ormond Beach, Florida, 32174
Arizona Research Center
Phoenix, Arizona, 85023
Gold Coast Research
Plantation, Florida, 33317
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206
Health Concepts
Rapid City, South Dakota, 57702
Hypothe Test, LLC
Roanoke, Virginia, 24018
Innovative Clinical Trials
San Antonio, Texas, 78229
Invisions Consultants, LLC
San Antonio, Texas, 78229
River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Georgia Clinical Research
Snellville, Georgia, 30078
Clinical Trial Network
Spring, Texas, 77386
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, 50265
Upstate Clinical Research Associates
Williamsville, New York, 14221
CRI Worldwide, LLC
Willingboro, New Jersey, 08046
Center for Clinical Research LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
Read the detailed description
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Placebo, Hydrocodone bitartrate
- Keywords
- chronic pain, back pain
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
Capsules, no active substance, shells identical to active comparator capsules
Hydrocodone bitartrateDrug
dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg
| Study group | Role | What they receive |
|---|---|---|
| Hydrocodone Bitartrate Capsules | Active comparator | Hydrocodone Bitartrate Controlled-Release Capsules Receives: Drug: Hydrocodone bitartrate |
| Placebo comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).
Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.
Measured: Baseline to Day 85 (Treatment Phase)
Secondary outcomes (1)
Mean Change of the Clinic NRS Pain Intensity
The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)
Measured: Baseline to Day 85 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
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 Back Pain Lower Back ChronicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Romanko, DPM, Study director, Zogenix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081912
- Sponsor's protocol ID
- ZX002-0801
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2010
- Last updated
- 8 Dec 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01081912
- Acronym / sponsor ID
- ZX002-0801
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- chronic pain, back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
Detailed description
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocodone Bitartrate Capsules | Active comparator | Drug: Hydrocodone bitartrateHydrocodone Bitartrate Controlled-Release Capsules |
| Placebo comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must have a clinical diagnosis of moderate to severe chronic lower back pain (CLBP)
- Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery
- Subjects must in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their chronic lower back pain (CLBP).
- Subjects must have been taking opioids for at least 5 days/week for the past 4weeks
- Subjects must have an average Clinic Pain Score of ≥ 4 on the 11-point (0-10) numeric rating scale (NRS) as an average for the last 24 hours of Screening
Key exclusion criteria (10 listed)
- Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or increase the risk of opioid-related adverse events
- A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug
- A surgical procedure for back pain within 6 months
- A nerve or plexus block, including epidural steroid injections or facet blocks
- A history of chemotherapy or confirmed malignancy within past 2 years
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 |
|---|---|---|
| PlaceboAlso: Sugar pillCapsules, no active substance, shells identical to active comparator capsules | Drug | Placebo comparator |
| Hydrocodone bitartratedosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg | Drug | Hydrocodone Bitartrate Capsules |
Primary outcome
Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).
Time frame: Baseline to Day 85 (Treatment Phase)
Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.
1 secondary outcome
Mean Change of the Clinic NRS Pain Intensity
Time frame: Baseline to Day 85 visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kevin Romanko, DPM study director
Zogenix, Inc.
51 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 Back Pain Lower Back Chronic, run by Zogenix, Inc. at 51 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 8 inclusion and 10 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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 21 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 24-hour Pain Intensity Ratings Scale (NRS). (time frame: Baseline to Day 85 (Treatment Phase)). 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 8 Dec 2022.