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Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01081912•Zogenix, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (51)

Arizona Research Center

Phoenix, Arizona, United States

Clopton Clinic

Jonesboro, Arkansas, United States

Advanced Clinical Research Institute

Anaheim, California, United States

Neuro-Pain Medical Center, Inc.

Fresno, California, United States

Pacific Coast Pain Management Center

Laguna Hills, California, United States

Clinicos, LLC

Colorado Springs, Colorado, United States

Interwest Rehabilitation, LLC

Littleton, Colorado, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Florida Institute of Medical Research

Jacksonville, Florida, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

December 8, 2022

Enrollment

510

ACTUAL participants

Conditions

Back Pain Lower Back Chronic

Interventions

Placebo

DRUG

Hydrocodone bitartrate

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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