Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452529
• Other study ID #: HYD3002
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2020
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Recruitment information / eligibility

• Status: Completed
• Enrollment: 905
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include:

• Male and female subjects = 18 years of age with moderate to severe, chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;

• Subjects whose low back pain is not adequately treated prior to the screening visit with their stable incoming analgesic regimen;

• Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to be appropriate candidates for the protocol specified, around the clock HYD therapeutic regimen;

• Female subjects who are premenopausal or postmenopausal less than 1 year and who have not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (eg, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception).

Exclusion Criteria include:

• Subjects taking > 100 mg/day oxycodone or equivalent during last 14 days prior to screening visit;

• Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain, excluding herbal and nutraceutical medications;

• Subjects who cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, botulinum toxin injections for control of chronic low back pain, steroid injections in the lower back or inhalation analgesia). The subject must not have had a nerve/plexus block within 4 weeks of the screening visit, neuroablation within 6 months of the screening visit, a botulinum toxin injection in the low back region within 3 months of the screening visit, steroid injections in the lower back within 6 weeks of the screening visit, or intravenous or intramuscular steroid injections within 4 weeks of the screening visit;

• Subjects who have used any investigational medication within 30 days prior to the first dose of study medication;

• Subjects with any history of seizures (subjects with history of pediatric febrile seizures may participate in the study) or increase in intracranial pressure;

• Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on a stable medication for = 1 month prior to the screening visit to participate in the study);

• Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;

• Subjects with clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker;

• Subjects with unstable respiratory disease that, in the opinion of the investigator, precludes entry into this study;

• Subjects with evidence of impaired liver function upon entry into the study (laboratory test values = 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT], or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study;

• Subjects with evidence of impaired kidney function upon entry into the study (ie, serum creatinine = 2.5 mg/dL);

• Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that, in the opinion of the investigator, is inadequately treated and precludes entry into the study;

• Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or scheduled for surgery of the lower back or any other major surgery during the study conduct period;

• Subjects with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;

• Subjects with any condition in which opioids are contraindicated, eg, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;

• Subjects who are allergic to hydrocodone or who have a history of allergies to other opioids. This does not include subjects who have experienced common opioid side effects (eg, nausea, constipation);

• Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within 2 weeks of the screening visit.

Other protocol-specific inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Hydrocodone bitartrate q24h film-coated tablets
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
• Placebo to match hydrocodone bitartrate q24h tablets
Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Locations

Country	Name	City	State
United States	Daystar Clinical Research, Inc.	Akron	Ohio
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Allegheny Pain Management, P.C.	Altoona	Pennsylvania
United States	ACRI-Phase 1, LLC	Anaheim	California
United States	Orange County Research Institute	Anaheim	California
United States	United Clinical Research Center, Inc.	Anaheim	California
United States	Hartwell Research Group	Anderson	South Carolina
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	QUEST Research Institute	Bingham Farms	Michigan
United States	Alliance Clinical Research	Birmingham	Alabama
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	Meridien Research	Bradenton	Florida
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Illinois Center for Clinical Research	Chicago	Illinois
United States	Community Research	Cincinnati	Ohio
United States	IVA Research	Cincinnati	Ohio
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Community Research	Crestview Hills	Kentucky
United States	KRK Medical Research	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Washington Center for Pain Management	Edmonds	Washington
United States	Florida Health Center	Fort Lauderdale	Florida
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Research Center of Fresno, Inc.	Fresno	California
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Drug Trials America	Hartsdale	New York
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Comprehensive Pain Specialists, LLC	Hendersonville	Tennessee
United States	AGA Clinical Trials	Hialeah	Florida
United States	Heights Doctor's Clinic	Houston	Texas
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	TriWest Research Associates	La Mesa	California
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Research Facility	Las Vegas	Nevada
United States	Fidelity Clinical Research, Inc.	Lauderhill	Florida
United States	Torrance Clinical Research Institute Inc.	Lomita	California
United States	Skyline Research, LLC	Long Beach	California
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
United States	Taylor Research, LLC	Marietta	Georgia
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	International Research Associates, LLC	Miami	Florida
United States	Neuroscience Consultants LLC	Miami	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	Heartland Medical, PC	New Tazewell	Tennessee
United States	The Medical Research Network, LLC	New York	New York
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Journey Research, Inc	Oldsmar	Florida
United States	Quality Clinical Research	Omaha	Nebraska
United States	Aspen Clinical Research	Orem	Utah
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Peninsula Research Inc.	Ormond Beach	Florida
United States	ICRI	Overland Park	Kansas
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Founders Research Corporation	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Redpoint Research	Phoenix	Arizona
United States	Advent Clinical Research Centers, Inc.	Pinellas Park	Florida
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Center for Clinical Research, Inc.	Richmond	California
United States	HypotheTest, LLC	Roanoke	Virginia
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Northern California Research	Sacramento	California
United States	Advance Clinical Research	Saint Louis	Missouri
United States	Medex Healthcare Research, Inc.	Saint Louis	Missouri
United States	Mercy Health Research	Saint Louis	Missouri
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Sun Research Institute	San Antonio	Texas
United States	Sarasota Research, LLC	Sarasota	Florida
United States	HCCA Clinical Research Solutions	Smyrna	Tennessee
United States	Encompass Clinical Research	Spring Valley	California
United States	Atlanta Knee and Shoulder Clinic, PC	Stockbridge	Georgia
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Tipton Medical & Diagnostic Center	Tipton	Pennsylvania
United States	Bone Joint and Spine Surgeons, Inc.	Toledo	Ohio
United States	IRC Clinics, Inc.	Towson	Maryland
United States	Medical Research Associates, Inc.	Traverse City	Michigan
United States	Genova Clinical Research	Tucson	Arizona
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Redpoint Research	Tucson	Arizona
United States	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Advanced Clinical Research	West Jordan	Utah
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	CRI Worldwide LLC	Willingboro	New Jersey
United States	PMG Research of Wilmington LLC	Wilmington	North Carolina
United States	Clinical Trials of America, Inc.	Winston-Salem	North Carolina
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wen W, Sitar S, Lynch SY, He E, Ripa SR. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score	Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).	Week 12
Secondary	Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale	The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern.	Weeks 4, 8, and 12
Secondary	Patient Global Impression of Change (PGIC)	The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "very much improved" and "much improved" was summarized by treatment group.	Week 12
Secondary	Responder Analysis for Subjects With a = 30% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.	Baseline to Week 12
Secondary	Responder Analysis for Subjects With a = 50% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.	Baseline to Week 12

External Links

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