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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01081912
First received: March 4, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Back Pain Lower Back Chronic
Drug: Placebo
Drug: Hydrocodone bitartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Mean Change in 24-hour Pain Intensity Ratings Scale (NRS). [ Time Frame: Baseline to Day 85 (Treatment Phase) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)


Enrollment: 510
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081912

  Show 51 Study Locations
Sponsors and Collaborators
Zogenix, Inc.
Investigators
Study Director: Kevin Romanko, DPM Zogenix, Inc.
  More Information

No publications provided

Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01081912     History of Changes
Other Study ID Numbers: ZX002-0801
Study First Received: March 4, 2010
Results First Received: February 4, 2014
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
chronic pain
back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hydrocodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 27, 2014