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

Sponsor:	Zogenix, Inc.
Information provided by:	Zogenix, Inc.
ClinicalTrials.gov Identifier:	NCT01081912

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
Chronic Low Back Pain	Drug: Placebo Drug: Hydrocodone bitartrate	Phase III

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:

MedlinePlus related topics: Back Pain

Drug Information available for: Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

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 a 0-10 Numerical Rating Scale (NRS) comparing HC-CR with Placebo.

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)

Estimated Enrollment:	340
Study Start Date:	March 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 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 Other Name: HC-CR
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 HC-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 CLBP
Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after LBP surgery
Subjects must in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their 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) 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

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

Show 51 Study Locations

Sponsors and Collaborators

Zogenix, Inc.

Investigators

Study Director:

Anthony Fox, MD

Zogenix, Inc.

More Information

No publications provided

Responsible Party:	Anthony Fox, MD Acting CMO, Zogenix, Inc.
ClinicalTrials.gov Identifier:	NCT01081912 History of Changes
Other Study ID Numbers:	ZX002-0801
Study First Received:	March 4, 2010
Last Updated:	February 23, 2011
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
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012