Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01428583
First received: September 2, 2011
Last updated: August 22, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Noncancer Pain |
Drug: oxycodone HCl and naltrexone HCl extended-release capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Oxycodone
Oxycodone hydrochloride
Naltrexone
Naltrexone hydrochloride
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Subjects with adverse reactions (AEs assessed by the investigator as treatment-related) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
- Subjects with treatment-emergent adverse events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Mean Cobs of oxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Mean observed steady-state plasma concentration (Cobs) of oxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Mean time to stabilization of the total daily dose of study drug [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
- Mean duration of exposure to study drug [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
- Mean daily dose of study drug during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
- Subjects with a positive urine drug test for illicit drug substances or unaccounted opioids, or a negative urine test for the expected opioid oxycodone [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
- Subjects with a Current Opioid Misuse Measure (COMM) score of 9 or above [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
- Mean Cobs of 6-ß-naltrexol at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Mean Cobs of 6-ß-naltrexol at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Mean Cobs of naltrexone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Mean Cobs of noroxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean Cobs of oxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
- Mean weekly number of acetaminophen tablets as rescue medication during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
- Mean number of acetaminophen tablets as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
- Mean daily dosage of immediate-release oxycodone as rescue medication during week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
- Mean daily dosage of immediate-release oxycodone as rescue medication during week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
- Mean daily dosage of immediate-release oxycodone as rescue medication during week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
- Mean daily dosage of immediate-release oxycodone as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 11 months [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 10 months [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Mean change from baseline to 12 months or early discontinuation in 'pain right now' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean change from baseline to 12 months in 'pain right now' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 11 months in 'pain right now' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 10 months in 'pain right now' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 9 months in 'pain right now' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 8 months in 'pain right now' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 7 months in 'pain right now' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 6 months in 'pain right now' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 5 months in 'pain right now' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 4 months in 'pain right now' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 3 months in 'pain right now' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 2 months in 'pain right now' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 4 weeks in 'pain right now' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
- Mean change from baseline to 1 week in 'pain right now' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
- Mean change from baseline to 12 months or early discontinuation in 'average pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean change from baseline to 12 months or early discontinuation in 'worst pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
- Mean change from baseline to 12 months in 'average pain' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 11 months in 'average pain' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 10 months in 'average pain' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
- Mean change from baseline to 9 months in 'average pain' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
| Enrollment: | 396 |
| Study Start Date: | December 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: oxycodone HCl and naltrexone HCl extended-release capsules |
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.)
Other Name: ALO-02
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428583
Hide Study Locations
Hide Study LocationsLocations
| United States, Florida | |
| Avail Clinical Research, LLC | |
| DeLand, Florida, United States, 32720 | |
| Florida Institute of Medical Research | |
| Jacksonville, Florida, United States, 32257 | |
| Drug Study Institute | |
| Jupiter, Florida, United States, 33458 | |
| Ormond Medical Arts Pharmaceutical Research Center | |
| Ormond Beach, Florida, United States, 32174 | |
| Peninsula Research, Inc. | |
| Ormond Beach, Florida, United States, 32174 | |
| Accord Clinical Research | |
| Port Orange, Florida, United States, 32129 | |
| Sarasota Pain Medicine Research | |
| Sarasota, Florida, United States, 34238 | |
| Clinical Research of West Florida | |
| Tampa, Florida, United States, 33603 | |
| United States, Georgia | |
| Center for Prospective Outcome Studies, Inc. | |
| Atlanta, Georgia, United States, 30327 | |
| Drug Studies America | |
| Marietta, Georgia, United States, 30060 | |
| Non-Surgical Orthopedics, P.C. | |
| Marietta, Georgia, United States, 30060 | |
| United States, Kentucky | |
| The Pain Treatment Center of the Bluegrass | |
| Lexington, Kentucky, United States, 40503 | |
| Commonwealth Biomedical Research | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maryland | |
| Crossroads Research | |
| Owings Mills, Maryland, United States, 21117 | |
| United States, Massachusetts | |
| Future Care Studies | |
| Springfield, Massachusetts, United States, 01105 | |
| United States, Minnesota | |
| MAPS Applied Research Center | |
| Edina, Minnesota, United States, 55435 | |
| United States, Mississippi | |
| Midsouth Anesthesia Consultants for Pain Management | |
| Southaven, Mississippi, United States, 38671 | |
| United States, Missouri | |
| Healthcare Research, LLC | |
| Florissant, Missouri, United States, 63031 | |
| United States, Montana | |
| Montana Neuroscience Institute | |
| Missoula, Montana, United States, 59802 | |
| United States, New Jersey | |
| Comprehensive Clinical Research | |
| Berlin, New Jersey, United States, 08009 | |
| United States, New York | |
| Drug Trials America - New York | |
| Hartsdale, New York, United States, 10530 | |
| New York and Spine and Wellness Center | |
| North Syracuse, New York, United States, 13212 | |
| Upstate Clinical Research Associates | |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Center for Clinical Research, LLC - Winston-Salem | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Columbus Clinical Research, Inc. | |
| Columbus, Ohio, United States, 43213 | |
| United States, Pennsylvania | |
| Allegheny Pain Management, PC | |
| Altoona, Pennsylvania, United States, 16602 | |
| United States, Texas | |
| FutureSearch Clinical Trials | |
| Austin, Texas, United States, 78731 | |
| KRK Medical Research | |
| Dallas, Texas, United States, 75230 | |
| Benchmark Research - Fort Worth | |
| Fort Worth, Texas, United States, 76135 | |
| Quality Research, Inc. | |
| San Antonio, Texas, United States, 78209 | |
| United States, Utah | |
| Lifetree Clinical Research | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| Hypothetest, LLC | |
| Roanoke, Virginia, United States, 24018 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01428583 History of Changes |
| Other Study ID Numbers: | ALO-02-10-3001, B4531001 |
| Study First Received: | September 2, 2011 |
| Last Updated: | August 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Chronic noncancer pain oxycodone naltrexone |
Additional relevant MeSH terms:
|
Naltrexone Oxycodone Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 22, 2013