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Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT01081912
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : April 21, 2014
Last Update Posted : December 8, 2022
Information provided by (Responsible Party):
UCB Pharma ( Zogenix, Inc. )

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

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

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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
Active Comparator: Hydrocodone Bitartrate Capsules
Hydrocodone Bitartrate Controlled-Release Capsules
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 :
  1. 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 :
  1. 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)

Information from the National Library of Medicine

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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

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

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Sponsors and Collaborators
Zogenix, Inc.
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Study Director: Kevin Romanko, DPM Zogenix, Inc.
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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. ):
chronic pain
back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents