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

Primary Purpose

Back Pain Lower Back Chronic

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Hydrocodone bitartrate
Sponsored by
Zogenix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring chronic pain, back pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Research Center
  • Clopton Clinic
  • Advanced Clinical Research Institute
  • Neuro-Pain Medical Center, Inc.
  • Pacific Coast Pain Management Center
  • Clinicos, LLC
  • Interwest Rehabilitation, LLC
  • Stamford Therapeutics Consortium
  • Clinical Research of West Florida, Inc.
  • Florida Institute of Medical Research
  • Peninsula Research, Inc.
  • Gold Coast Research
  • Clinical Research of West Florida, Inc.
  • Perimeter Institute for Clinical Research, Inc.
  • River Birch Research Alliance, LLC
  • Georgia Institute for Clinical Research, LLC
  • Georgia Clinical Research
  • Suburban Clinical Research
  • Destiny Clinical Research, LLC
  • Integrated Clinical Trials Services, Inc.
  • International Clinical Research Institute
  • Clinical Trials Technology, Inc
  • Cotton O'Neil Clinical Research Center
  • Clinical Trials Management
  • Best Clinical Trials, LLC
  • River Cities Clinical Research Center
  • NECCR Internal Medicine & Cardiology Associates, LLC
  • Center for Clinical Trials
  • Research West, LLC
  • Office of Danka Michaels, MD
  • South Jersey Medical Associates
  • CRI Worldwide, LLC
  • Five Towns Neuroscience Research
  • Upstate Clinical Research Associates
  • Center for Clinical Research LLC
  • IVA Research
  • Prestige Clinical Research
  • Neuropsychiatric Research Center
  • Brandywine Clinical Research
  • Feasterville Family Health Care Center
  • New England Center for Clinical Research
  • Health Concepts
  • Integrity Clinical Research, LLC
  • InSite Clinical Research
  • Clinical Trial Network
  • Innovative Clinical Trials
  • Invisions Consultants, LLC
  • Clinical Trial Network
  • Advanced Research Institute
  • Hypothe Test, LLC
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hydrocodone Bitartrate Capsules

Placebo comparator

Arm Description

Hydrocodone Bitartrate Controlled-Release Capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
March 4, 2010
Last Updated
November 8, 2022
Sponsor
Zogenix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01081912
Brief Title
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zogenix, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
chronic pain, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocodone Bitartrate Capsules
Arm Type
Active Comparator
Arm Description
Hydrocodone Bitartrate Controlled-Release Capsules
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Capsules, no active substance, shells identical to active comparator capsules
Intervention Type
Drug
Intervention Name(s)
Hydrocodone bitartrate
Intervention Description
dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg
Primary Outcome Measure Information:
Title
Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).
Description
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.
Time Frame
Baseline to Day 85 (Treatment Phase)
Secondary Outcome Measure Information:
Title
Mean Change of the Clinic NRS Pain Intensity
Description
The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)
Time Frame
Baseline to Day 85 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Romanko, DPM
Organizational Affiliation
Zogenix, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Clopton Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Neuro-Pain Medical Center, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Pacific Coast Pain Management Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Interwest Rehabilitation, LLC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Peninsula Research, Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Gold Coast Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Perimeter Institute for Clinical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Suburban Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60490
Country
United States
Facility Name
Destiny Clinical Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Integrated Clinical Trials Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
International Clinical Research Institute
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Clinical Trials Technology, Inc
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Best Clinical Trials, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
NECCR Internal Medicine & Cardiology Associates, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Center for Clinical Trials
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Research West, LLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Office of Danka Michaels, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
South Jersey Medical Associates
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Center for Clinical Research LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
IVA Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Neuropsychiatric Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Feasterville Family Health Care Center
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Invisions Consultants, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trial Network
City
Spring
State/Province
Texas
ZIP/Postal Code
77386
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Hypothe Test, LLC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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