Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
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| ClinicalTrials.gov Identifier: NCT01081912 |
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Recruitment Status :
Completed
First Posted : March 5, 2010
Results First Posted : April 21, 2014
Last Update Posted : December 8, 2022
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Sponsor:
Zogenix, Inc.
Information provided by (Responsible Party):
UCB Pharma ( Zogenix, Inc. )
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Back Pain Lower Back Chronic | Drug: Placebo Drug: Hydrocodone bitartrate | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 510 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | October 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Hydrocodone Bitartrate Capsules
Hydrocodone Bitartrate Controlled-Release Capsules
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Drug: Hydrocodone bitartrate
dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg |
| Placebo Comparator: Placebo comparator |
Drug: Placebo
Capsules, no active substance, shells identical to active comparator capsules
Other Name: Sugar pill |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Mean Change of the Clinic NRS Pain Intensity [ Time Frame: Baseline to Day 85 visit ]The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081912
Locations
Show 51 study locations
Sponsors and Collaborators
Zogenix, Inc.
Investigators
| Study Director: | Kevin Romanko, DPM | Zogenix, Inc. |
| Responsible Party: | Zogenix, Inc. |
| ClinicalTrials.gov Identifier: | NCT01081912 |
| Other Study ID Numbers: |
ZX002-0801 |
| First Posted: | March 5, 2010 Key Record Dates |
| Results First Posted: | April 21, 2014 |
| Last Update Posted: | December 8, 2022 |
| Last Verified: | March 2014 |
Keywords provided by UCB Pharma ( Zogenix, Inc. ):
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chronic pain back pain |
Additional relevant MeSH terms:
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Back Pain Low Back Pain Pain Neurologic Manifestations Hydrocodone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |