Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Chronic Noncancer Pain Clinical Trial

Official title:

A Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428583
• Other study ID #: ALO-02-10-3001
• Secondary ID: B4531001
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2011
• Last updated: July 8, 2013
• Start date: December 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.

• Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Exclusion Criteria:

• Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).

• Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.

• Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.

• Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.

• Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.

• If female, the subject is pregnant or breast-feeding.

• Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.

• Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Noncancer Pain

Intervention

Drug:
• oxycodone HCl and naltrexone HCl extended-release capsules
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Locations

Country	Name	City	State
United States	Allegheny Pain Management, PC	Altoona	Pennsylvania
United States	Center for Prospective Outcome Studies, Inc.	Atlanta	Georgia
United States	FutureSearch Clinical Trials	Austin	Texas
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Columbus Clinical Research, Inc.	Columbus	Ohio
United States	KRK Medical Research	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	MAPS Applied Research Center	Edina	Minnesota
United States	Healthcare Research, LLC	Florissant	Missouri
United States	Benchmark Research - Fort Worth	Fort Worth	Texas
United States	Drug Trials America - New York	Hartsdale	New York
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Drug Study Institute	Jupiter	Florida
United States	The Pain Treatment Center of the Bluegrass	Lexington	Kentucky
United States	Commonwealth Biomedical Research	Madisonville	Kentucky
United States	Drug Studies America	Marietta	Georgia
United States	Non-Surgical Orthopedics, P.C.	Marietta	Georgia
United States	Montana Neuroscience Institute	Missoula	Montana
United States	New York and Spine and Wellness Center	North Syracuse	New York
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	Peninsula Research, Inc.	Ormond Beach	Florida
United States	Crossroads Research	Owings Mills	Maryland
United States	Accord Clinical Research	Port Orange	Florida
United States	Hypothetest, LLC	Roanoke	Virginia
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Quality Research, Inc.	San Antonio	Texas
United States	Sarasota Pain Medicine Research	Sarasota	Florida
United States	Midsouth Anesthesia Consultants for Pain Management	Southaven	Mississippi
United States	Future Care Studies	Springfield	Massachusetts
United States	Clinical Research of West Florida	Tampa	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Center for Clinical Research, LLC - Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects with adverse reactions (AEs assessed by the investigator as treatment-related)		up to 12 months	Yes
Primary	Subjects with treatment-emergent adverse events		up to 12 months	Yes
Secondary	Mean Cobs of oxycodone at 6 months		6 months	No
Secondary	Mean Cobs of oxycodone at 3 months		3 months	No
Secondary	Mean Cobs of oxycodone at 2 months		2 months	No
Secondary	Mean Cobs of oxycodone at 4 weeks		4 weeks	No
Secondary	Mean observed steady-state plasma concentration (Cobs) of oxycodone at 1 week		1 week	No
Secondary	Mean time to stabilization of the total daily dose of study drug		up to 12 months	No
Secondary	Mean duration of exposure to study drug		12 months	No
Secondary	Mean daily dose of study drug during month 12		month 12	No
Secondary	Mean daily dose of study drug during month 11		month 11	No
Secondary	Mean daily dose of study drug during month 10		month 10	No
Secondary	Mean daily dose of study drug during month 9		month 9	No
Secondary	Mean daily dose of study drug during month 8		month 8	No
Secondary	Mean daily dose of study drug during month 7		month 7	No
Secondary	Mean daily dose of study drug during month 6		month 6	No
Secondary	Mean daily dose of study drug during month 5		month 5	No
Secondary	Mean daily dose of study drug during month 4		month 4	No
Secondary	Mean daily dose of study drug during month 3		month 3	No
Secondary	Mean daily dose of study drug during month 2		month 2	No
Secondary	Mean daily dose of study drug during first 4 weeks		week 1 to week 4	No
Secondary	Mean daily dose of study drug during week 1		week 1	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 12		month 12	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 11		month 11	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 10		month 10	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 9		month 9	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 8		month 8	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 7		month 7	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 6		month 6	No
Secondary	Subjects with a positive urine drug test for illicit drug substances or unaccounted opioids, or a negative urine test for the expected opioid oxycodone		up to 12 months	Yes
Secondary	Subjects with a Current Opioid Misuse Measure (COMM) score of 9 or above		up to 12 months	Yes
Secondary	Mean Cobs of 6-ß-naltrexol at 12 months or early discontinuation		12 months or early discontinuation	No
Secondary	Mean Cobs of 6-ß-naltrexol at 12 months		12 months	No
Secondary	Mean Cobs of 6-ß-naltrexol at 9 months		9 months	No
Secondary	Mean Cobs of 6-ß-naltrexol at 6 months		6 months	No
Secondary	Mean Cobs of 6-ß-naltrexol at 3 months		3 months	No
Secondary	Mean Cobs of 6-ß-naltrexol at 2 months		2 months	No
Secondary	Mean Cobs of 6-ß-naltrexol at 4 weeks		4 weeks	No
Secondary	Mean Cobs of 6-ß-naltrexol at 1 week		1 week	No
Secondary	Mean Cobs of naltrexone at 12 months or early discontinuation		12 months or early discontinuation	No
Secondary	Mean Cobs of naltrexone at 12 months		12 months	No
Secondary	Mean Cobs of naltrexone at 9 months		9 months	No
Secondary	Mean Cobs of naltrexone at 6 months		6 months	No
Secondary	Mean Cobs of naltrexone at 3 months		3 months	No
Secondary	Mean Cobs of naltrexone at 2 months		2 months	No
Secondary	Mean Cobs of naltrexone at 4 weeks		4 weeks	No
Secondary	Mean Cobs of naltrexone at 1 week		1 week	No
Secondary	Mean Cobs of noroxycodone at 12 months or early discontinuation		12 months or early discontinuation	No
Secondary	Mean Cobs of noroxycodone at 12 months		12 months	No
Secondary	Mean Cobs of noroxycodone at 9 months		9 months	No
Secondary	Mean Cobs of noroxycodone at 6 months		6 months	No
Secondary	Mean Cobs of noroxycodone at 3 months		3 months	No
Secondary	Mean Cobs of noroxycodone at 2 months		2 months	No
Secondary	Mean Cobs of noroxycodone at 4 weeks		4 weeks	No
Secondary	Mean Cobs of noroxycodone at 1 week		1 week	No
Secondary	Mean Cobs of oxycodone at 12 months or early discontinuation		12 months or early discontinuation	No
Secondary	Mean Cobs of oxycodone at 12 months		12 months	No
Secondary	Mean Cobs of oxycodone at 9 months		9 months	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 5		month 5	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 4		month 4	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 3		month 3	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during month 2		month 2	No
Secondary	Mean weekly number of acetaminophen tablets as rescue medication during first 4 weeks		week 1 to week 4	No
Secondary	Mean number of acetaminophen tablets as rescue medication during week 1		week 1	No
Secondary	Mean daily dosage of immediate-release oxycodone as rescue medication during week 4		week 4	No
Secondary	Mean daily dosage of immediate-release oxycodone as rescue medication during week 3		week 3	No
Secondary	Mean daily dosage of immediate-release oxycodone as rescue medication during week 2		week 2	No
Secondary	Mean daily dosage of immediate-release oxycodone as rescue medication during week 1		week 1	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months or early discontinuation		12 months or early discontinuation	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months		12 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 11 months		11 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 10 months		10 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 9 months		9 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 8 months		8 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 7 months		7 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 6 months		6 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 5 months		5 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 months		4 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 3 months		3 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 2 months		2 months	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 weeks		4 weeks	No
Secondary	Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 1 week		1 week	No
Secondary	Mean change from baseline to 12 months or early discontinuation in 'pain right now' score		baseline to 12 months or early discontinuation	No
Secondary	Mean change from baseline to 12 months in 'pain right now' score		baseline to 12 months	No
Secondary	Mean change from baseline to 11 months in 'pain right now' score		baseline to 11 months	No
Secondary	Mean change from baseline to 10 months in 'pain right now' score		baseline to 10 months	No
Secondary	Mean change from baseline to 9 months in 'pain right now' score		baseline to 9 months	No
Secondary	Mean change from baseline to 8 months in 'pain right now' score		baseline to 8 months	No
Secondary	Mean change from baseline to 7 months in 'pain right now' score		baseline to 7 months	No
Secondary	Mean change from baseline to 6 months in 'pain right now' score		baseline to 6 months	No
Secondary	Mean change from baseline to 5 months in 'pain right now' score		baseline to 5 months	No
Secondary	Mean change from baseline to 4 months in 'pain right now' score		baseline to 4 months	No
Secondary	Mean change from baseline to 3 months in 'pain right now' score		baseline to 3 months	No
Secondary	Mean change from baseline to 2 months in 'pain right now' score		baseline to 2 months	No
Secondary	Mean change from baseline to 4 weeks in 'pain right now' score		baseline to 4 weeks	No
Secondary	Mean change from baseline to 1 week in 'pain right now' score		baseline to 1 week	No
Secondary	Mean change from baseline to 12 months or early discontinuation in 'average pain' score		baseline to 12 months or early discontinuation	No
Secondary	Mean change from baseline to 12 months or early discontinuation in 'worst pain' score		baseline to 12 months or early discontinuation	No
Secondary	Mean change from baseline to 12 months in 'average pain' score		baseline to 12 months	No
Secondary	Mean change from baseline to 11 months in 'average pain' score		baseline to 11 months	No
Secondary	Mean change from baseline to 10 months in 'average pain' score		baseline to 10 months	No
Secondary	Mean change from baseline to 9 months in 'average pain' score		baseline to 9 months	No

External Links

•   To obtain contact information for a study center near you, click here.